Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
Active, enrolledPhase 3Results postedLast updated 25 November 2025
What this trial tests
Phase 3 trial testing Bevacizumab in Borderline Ovarian Mucinous Tumor in 50 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
12 October 2010
Primary endpoint 25 February 2015
12 March 2026
Quick facts
Lead sponsor
National Cancer Institute (NCI)
Phase
Phase 3
Status
Active, enrolled
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
none
Primary purpose
treatment
Enrollment
50
Start date
12 October 2010
Primary completion
25 February 2015
Estimated completion
12 March 2026
Sites
248 locations across United States
Drugs / interventions tested
Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
18 and older, female only, with Borderline Ovarian Mucinous Tumor or Ovarian Mucinous Cystadenocarcinoma. 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.
Overall SurvivalPrimary· Up to five years
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
37.6
8.8 – NA
Arm II (Oxaliplatin and Capecitabine)
27.8
9.3 – NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
27.7
4.9 – 53.6
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
55.7
9.9 – NA
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0Secondary· Every cycle while on treatment, up to 5 years
Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.
Abnormal lab values
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
8
Arm II (Oxaliplatin and Capecitabine)
10
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
10
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
10
Allergic reaction
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
3
Arm II (Oxaliplatin and Capecitabine)
1
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
0
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
4
Allergic rhinitis
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
0
Arm II (Oxaliplatin and Capecitabine)
1
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
1
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
1
Alopecia
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
11
Arm II (Oxaliplatin and Capecitabine)
1
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
9
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
5
Anemia
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
12
Arm II (Oxaliplatin and Capecitabine)
7
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
4
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
6
Bleeding
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
1
Arm II (Oxaliplatin and Capecitabine)
1
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
3
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
5
Cold-like symptoms
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
2
Arm II (Oxaliplatin and Capecitabine)
3
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
7
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
6
Constipation
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
3
Arm II (Oxaliplatin and Capecitabine)
4
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
7
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
9
Progression-free SurvivalSecondary· 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.
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 (Carboplatin and Paclitaxel)
36.1
2.0 – NA
Arm II (Oxaliplatin and Capecitabine)
7.4
4.5 – NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
15.4
4.9 – NA
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
23.3
9.1 – NA
Objective Tumor ResponseSecondary· CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.\>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
22
3 – 60
Arm II (Oxaliplatin and Capecitabine)
27
6 – 61
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
43
10 – 82
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
40
5 – 85
Patient Reported NeurotoxicitySecondary· baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 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 Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered i
Baseline (pre-treatment)
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
16.0
± 0.0
Arm II (Oxaliplatin and Capecitabine)
15.3
± 1.2
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
14.3
± 2.9
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
16.0
± 0.0
Pre-cycle 4
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
7.3
± 4.2
Arm II (Oxaliplatin and Capecitabine)
11.8
± 5.3
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
12.7
± 3.5
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
5.7
± 4.9
Post cycle 6
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
6.5
± 2.1
Arm II (Oxaliplatin and Capecitabine)
11.7
± 4.0
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
11.0
± 5.6
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
8.0
± 6.3
Six months post chemo
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
5.0
± 4.2
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
11.3
± 5.7
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
10.7
± 2.3
End of bevacizumab (BEV)
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
16.0
± NA
Arm II (Oxaliplatin and Capecitabine)
10.0
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
9.5
± 4.9
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
11.7
± 3.8
Six months after BEV
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
10.0
± NA
Arm II (Oxaliplatin and Capecitabine)
10.0
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
9.0
± 4.2
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
7.0
± 9.9
2 years after BEV
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
8.0
± NA
Arm II (Oxaliplatin and Capecitabine)
14.0
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
5.5
± 4.9
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
16.0
± NA
3 years after BEV
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
14.0
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
9.5
± 4.9
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
16.0
± NA
Patient Reported Quality of LifeSecondary· baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI 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 statements (or questions), reversal was performed prior to score calcul
Baseline (pre-treatment)
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
62.6
± 12.6
Arm II (Oxaliplatin and Capecitabine)
62.3
± 29.5
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
68.7
± 9.7
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
75.4
± 15.9
Pre-Cycle 4
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
57.5
± 4.8
Arm II (Oxaliplatin and Capecitabine)
72.9
± 16.4
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
68.7
± 2.1
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
76.0
± 12.5
Post-Cycle 6
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
65.2
± 4.0
Arm II (Oxaliplatin and Capecitabine)
73.5
± 9.1
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
68.3
± 5.5
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
71.8
± 14.1
Six Months Post-Chemo
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
74.1
± 14.2
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
80.3
± 12.2
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
68.7
± 29.7
End of Bevacizumab (BEV)
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
68.9
± NA
Arm II (Oxaliplatin and Capecitabine)
53.3
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
73.0
± 22.6
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
49.9
± 31.4
Six Months after BEV
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
54.0
± NA
Arm II (Oxaliplatin and Capecitabine)
53.0
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
87.5
± 7.8
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
70.5
± 26.2
2 Years after BEV
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
71.7
± NA
Arm II (Oxaliplatin and Capecitabine)
56.0
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
76.3
± 15.2
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
77.0
± NA
3 Years after BEV
Group
Value
95% CI
Arm I (Carboplatin and Paclitaxel)
76.4
± NA
Arm III (Carboplatin, Paclitaxel, Bevacizumab)
80.5
± 17.7
Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)
76.0
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Study treatment and up to 5 years after treatment discontinuation.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07504588 — Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and
· Phase 2
· not yet recruiting
NCT07500298 — Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable
· Phase 1
· not yet recruiting
NCT07271355 — Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colore
· Phase 3
· not yet recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
· EARLY_PHASE1
· not yet recruiting
NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance
· Phase 2
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 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: 25 November 2025
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/NCT01081262.