Who is sponsoring NCT00951496?

NCT00951496 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00951496?

Interventions in NCT00951496: Bevacizumab, Carboplatin, Carboplatin, Cisplatin, Laboratory Biomarker Analysis, Paclitaxel, Paclitaxel, Quality-of-Life Assessment.

What condition does NCT00951496 study?

NCT00951496 studies Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Malignant Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Clear Cell Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Primary Peritoneal Transitional Cell Carcinoma, Primary Peritoneal Undifferentiated Carcinoma, Stage II Fallopian Tube Cancer AJCC v6 and v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Ovarian Cancer AJCC v6 and v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7.

Is NCT00951496 still recruiting?

NCT00951496 is currently completed. Last updated 4 May 2021.

Are results published for NCT00951496?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-05-04 · How we verify

NCT00951496

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Completed Phase 3 Results posted Last updated 4 May 2021

What this trial tests

Phase 3 trial testing Bevacizumab in Fallopian Tube Clear Cell Adenocarcinoma in 1,560 participants. Completed in 11 January 2016.

Timeline

11 August 2009

Primary endpoint
11 January 2016

11 January 2016

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,560
Start date	11 August 2009
Primary completion	11 January 2016
Estimated completion	11 January 2016
Sites	503 locations across United States

Drugs / interventions tested

Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Laboratory Biomarker Analysis
Paclitaxel — full drug profile →
Paclitaxel — full drug profile →
Quality-of-Life Assessment

Conditions studied

Fallopian Tube Clear Cell Adenocarcinoma — all drugs for Fallopian Tube Clear Cell Adenocarcinoma →
Fallopian Tube Endometrioid Adenocarcinoma — all drugs for Fallopian Tube Endometrioid Adenocarcinoma →
Fallopian Tube Mucinous Adenocarcinoma — all drugs for Fallopian Tube Mucinous Adenocarcinoma →
Fallopian Tube Serous Adenocarcinoma — all drugs for Fallopian Tube Serous Adenocarcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, female only, with Fallopian Tube Clear Cell Adenocarcinoma or Fallopian Tube Endometrioid Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Progression-free Survival Primary · Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.

Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)	24.9	22.3 – 27.2
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)	27.3	24.6 – 28.8
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)	26.0	23.8 – 28.0

Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 Secondary · During treatment and up to 30 days after end of treatment

Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event.

Adverse Event Grade 0

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)	0
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)	0
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)	1

Adverse Event Grade 1

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)	1
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)	0
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)	0

Adverse Event Grade 2

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)	48
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)	46
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)	52

Adverse Event Grade 3

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)	269
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)	300
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)	246

Adverse Event Grade 4

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)	185
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)	158
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)	199

Adverse Event Grade 5

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)	8
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)	6
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)	10

Overall Survival Secondary · Up to 10 years

Estimate the median duration of overall survival in months.

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	75.4	67.1 – NA
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	74.2	61.9 – 78.4
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	67.6	63.5 – 74.6

Patient Reported Quality of Life (QOL) Secondary · Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment

QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale it

Baseline

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	68.5	± 0.7
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	67.4	± 0.7
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	67.7	± 0.7

Prior to cycle 4

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	67.8	± 0.6
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	65.6	± 0.6
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	61.9	± 0.6

Prior to cycle 7

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	69.1	± 0.6
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	68.2	± 0.6
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	65.7	± 0.7

Prior to cycle 13

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	77.3	± 0.6
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	77.1	± 0.6
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	78.4	± 0.6

Prior to cycle 21

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	77.7	± 0.6
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	76.9	± 0.7
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	78.2	± 0.6

84 weeks

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	78.3	± 0.7
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	77.7	± 0.7
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	79.4	± 0.7

Patient Reported Neurotoxicity (Ntx) Secondary · Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment

The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item

Baseline

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	15.4	± 0.1
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	15.4	± 0.1
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	15.4	± 0.1

Prior to cycle 4

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	12.9	± 0.2
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	13.0	± 0.2
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	13.6	± 0.2

Prior to cycle 7

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	10.4	± 0.2
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	10.3	± 0.2
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	10.9	± 0.2

Prior to cycle 13

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	11.1	± 0.2
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	10.5	± 0.2
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	9.2	± 0.2

Prior to cycle 21

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	11.4	± 0.2
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	11.1	± 0.2
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	11.0	± 0.2

84 weeks

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	11.9	± 0.2
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	11.4	± 0.2
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	11.5	± 0.2

Patient Reported Fatigue Secondary · Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment

Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of

Baseline

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	35.3	± 0.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	35.1	± 0.3
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	35.3	± 0.3

Prior to cycle 4

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	32.5	± 0.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	32.0	± 0.3
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	31.3	± 0.3

Prior to cycle 7

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	32.7	± 0.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	32.7	± 0.3
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	32.4	± 0.3

Prior to cycle 13

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	35.7	± 0.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	35.5	± 0.3
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	35.9	± 0.3

Prior to cycle 21

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	35.5	± 0.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	35.1	± 0.3
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	36.3	± 0.3

84 weeks

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	35.7	± 0.3
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	36.0	± 0.3
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	36.5	± 0.3

Patient Reported Nausea Secondary · Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment

Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much)

Baseline

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	0.4	± 0.04
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	0.4	± 0.04
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	0.4	± 0.04

Prior to cycle 4

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	0.6	± 0.04
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	0.7	± 0.04
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	1.1	± 0.05

Prior to cycle 7

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	0.5	± 0.04
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	0.5	± 0.04
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	0.7	± 0.05

Prior to cycle 13

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	0.2	± 0.03
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	0.3	± 0.03
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	0.2	± 0.03

Prior to cycle 21

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	0.3	± 0.04
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	0.4	± 0.04
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	0.3	± 0.03

84 Weeks

Group	Value	95% CI
Arm I (Paclitaxel, Carboplatin, Bevacizumab)	0.3	± 0.04
Arm II (Paclitaxel, Bevacizumab, Carboplatin IP)	0.4	± 0.04
Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)	0.3	± 0.03

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)

Serious: 156/511 (31%)

Deaths: —

Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)

Serious: 179/510 (35%)

Deaths: —

Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)

Serious: 215/508 (42%)

Deaths: —

Serious adverse events (179 terms)

Reaction	System	Arm I (Paclitaxel, Carbopl…	Arm II (Paclitaxel,carbopl…	Arm III (Paclitaxel IP, Ci…
Thrombosis/Thrombus/Embolism	Vascular disorders	—	—	—
Obstruction, Gi - Small Bowel Nos	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Pain: Abdominal Pain Nos	General disorders	—	—	—
Hypertension	Cardiac disorders	—	—	—
Neutrophils	Blood and lymphatic system disorders	—	—	—
Dehydration	Gastrointestinal disorders	—	—	—
Wound Complication, Non-Infectious	Skin and subcutaneous tissue disorders	—	—	—
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	Infections and infestations	—	—	—
Febrile Neutropenia	Infections and infestations	—	—	—
Syncope	Nervous system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Perforation, Gi - Colon	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	Infections and infestations	—	—	—
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos	Infections and infestations	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Cardiac Ischemia/Infarction	Cardiac disorders	—	—	—
Fever	General disorders	—	—	—
Ileus	Gastrointestinal disorders	—	—	—
Perforation, Gi - Small Bowel Nos	Gastrointestinal disorders	—	—	—
Inf W/Nml Or Gr 1 Or 2 Anc: Wound	Infections and infestations	—	—	—
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	Infections and infestations	—	—	—
Colitis, Infectious (Eg.C. Difficile)	Infections and infestations	—	—	—

Other adverse events (514 terms — click to expand)

Reaction	System	Arm I (Paclitaxel, Carbopl…	Arm II (Paclitaxel,carbopl…	Arm III (Paclitaxel IP, Ci…
Hemoglobin	Blood and lymphatic system disorders	—	—	—
Leukocytes	Blood and lymphatic system disorders	—	—	—
Neutrophils	Blood and lymphatic system disorders	—	—	—
Fatigue	General disorders	—	—	—
Neuropathy-Sensory	Nervous system disorders	—	—	—
Hair Loss/Alopecia (Scalp Or Body)	Skin and subcutaneous tissue disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Platelets	Blood and lymphatic system disorders	—	—	—
Pain: Abdominal Pain Nos	General disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Hemorrhage/Pulmonary - Nose	Vascular disorders	—	—	—
Hypertension	Cardiac disorders	—	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—	—
Pain: Joint	General disorders	—	—	—
Pain: Head/Headache	General disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Anorexia	Gastrointestinal disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Insomnia	General disorders	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Pain: Extremity-Limb	General disorders	—	—	—
Rhinitis	Immune system disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Pain: Muscle	General disorders	—	—	—
Nail Changes	Skin and subcutaneous tissue disorders	—	—	—
Creatinine	Metabolism and nutrition disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Mood Alteration - Anxiety	Nervous system disorders	—	—	—
Weight Gain	General disorders	—	—	—
Pain: Back	General disorders	—	—	—
Taste Alteration	Gastrointestinal disorders	—	—	—
Mucositis (Clinical Exam) - Oral Cavity	Gastrointestinal disorders	—	—	—
Mood Alteration - Depression	Nervous system disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Alanine Aminotransferases (Alt)	Metabolism and nutrition disorders	—	—	—
Heartburn	Gastrointestinal disorders	—	—	—
Edema: Limb	Blood and lymphatic system disorders	—	—	—

Most-reported serious reactions: Thrombosis/Thrombus/Embolism, Obstruction, Gi - Small Bowel Nos, Vomiting, Pain: Abdominal Pain Nos, Hypertension, Neutrophils, Dehydration, Wound Complication, Non-Infectious.

Data from ClinicalTrials.gov NCT00951496 adverse events section.

Sponsor's own description

This randomized phase III trial studies bevacizumab and intravenous (given into a vein) chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Latest research and treatment of advanced-stage epithelial ovarian cancer.
Coleman RL, Monk BJ, Sood AK, Herzog TJ. · · 2013 · cited 412× · PMID 23381004 · DOI 10.1038/nrclinonc.2013.5
Weekly vs. Every-3-Week Paclitaxel and Carboplatin for Ovarian Cancer.
Chan JK, Brady MF, Penson RT, Huang H, et al · · 2016 · cited 265× · PMID 26933849 · DOI 10.1056/nejmoa1505067
Long-term survival advantage and prognostic factors associated with intraperitoneal chemotherapy treatment in advanced ovarian cancer: a gynecologic oncology group study.
Tewari D, Java JJ, Salani R, Armstrong DK, et al · · 2015 · cited 188× · PMID 25800756 · DOI 10.1200/jco.2014.55.9898
Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study.
Walker JL, Brady MF, Wenzel L, Fleming GF, et al · · 2019 · cited 156× · PMID 31002578 · DOI 10.1200/jco.18.01568
Bevacizumab in ovarian cancer: A critical review of phase III studies.
Rossi L, Verrico M, Zaccarelli E, Papa A, et al · · 2017 · cited 84× · PMID 27852039 · DOI 10.18632/oncotarget.13310
Ovarian cancer standard of care: are there real alternatives?
Della Pepa C, Tonini G, Pisano C, Di Napoli M, et al · · 2015 · cited 73× · PMID 25556615 · DOI 10.5732/cjc.014.10274
Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer.
Haunschild CE, Tewari KS. · · 2020 · cited 72× · PMID 31746224 · DOI 10.2217/fon-2019-0042
Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper.
Herzog TJ, Armstrong DK, Brady MF, Coleman RL, et al · · 2014 · cited 58× · PMID 24239753 · DOI 10.1016/j.ygyno.2013.11.008

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00951496 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 4 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00951496.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00951496

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (179 terms)

Sponsor's own description

Publications & conference data

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Verify against primary sources