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NCT00993655

Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer

Completed Phase 2 Results posted Last updated 28 August 2023
What this trial tests

Phase 2 trial testing carboplatin in Fallopian Tube Cancer in 275 participants. Completed in 11 July 2016.

Timeline
3 March 2010
Primary endpoint
10 March 2016
11 July 2016

Quick facts

Lead sponsorCanadian Cancer Trials Group
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment275
Start date3 March 2010
Primary completion10 March 2016
Estimated completion11 July 2016
Sites50 locations across United Kingdom, Canada, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Canadian Cancer Trials Group — full company profile →

Who can join

18 and older, female only, with Fallopian Tube Cancer or Metastatic Cancer. 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.

9-month Progression Rate Post-randomization Primary · 9 months

It is defined as proportion of patients who had progressed at or before 9 months after randomization, i.e., the time from the randomization to the date when the first observation of disease progression (earliest of the date when the first CA 125 meets progression definition and the date of first objective relapse or progression, 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, recorded) has been documented o

GroupValue95% CI
Arm 10.386
Arm 20.347
Arm 30.245
Progression Free Survival Secondary · During the study with median follow-up of 33 months

Time from the day of randomization until the time when first observation of disease progression (earliest of the dates of first CA125 which meets progression definition and first objective relapse or progression 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, has been documented or when death due to any cause has been observed.

GroupValue95% CI
IV Carboplatin + IV Paclitaxel11.38.8 – 14.7
IP Cisplatin + IV/IP Paclitaxel12.79.7 – 18.0
IP Carboplatin + IV/IP Paclitaxel12.510.8 – 15.0
Overall Survival Secondary · During the study with median follow-up of 33 months

Time from the day of randomization to death from any cause.

GroupValue95% CI
IV Carboplatin + IV Paclitaxel38.132.9 – 47.7
IP Cisplatin + IV/IP Paclitaxel40.638.7 – 68.1
IP Carboplatin + IV/IP Paclitaxel59.334.2 – 68.3

Adverse events — posted to ClinicalTrials.gov

Time frame: During the time when patients were treated by protocol therapy, up to 9 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1
Serious: 7/95 (7%)
Deaths: 34/95
Arm 2
Serious: 8/67 (12%)
Deaths: 24/67
Arm 3
Serious: 6/92 (7%)
Deaths: 26/92

Serious adverse events (22 terms)

ReactionSystemArm 1Arm 2Arm 3
Febrile neutropeniaBlood and lymphatic system disorders
Infusion site extravasationGeneral disorders
AnemiaBlood and lymphatic system disorders
NauseaGastrointestinal disorders
Abdominal painGastrointestinal disorders
Neutrophil count decreasedInvestigations
Female genital tract fistulaReproductive system and breast disorders
Vaginal dischargeReproductive system and breast disorders
DyspneaRespiratory, thoracic and mediastinal disorders
ConstipationGastrointestinal disorders
Abdominal infectionInfections and infestations
Pelvic infectionInfections and infestations
HypokalemiaMetabolism and nutrition disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
SyncopeNervous system disorders
Pelvic painReproductive system and breast disorders
Thromboembolic eventVascular disorders
VomitingGastrointestinal disorders
Infusion related reactionGeneral disorders
Intraoperative gastrointestinal injuryInjury, poisoning and procedural complications
Vaginal hemorrhageReproductive system and breast disorders
Other adverse events (56 terms — click to expand)

ReactionSystemArm 1Arm 2Arm 3
FatigueGeneral disorders
AlopeciaRespiratory, thoracic and mediastinal disorders
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
Peripheral sensory neuropathyNervous system disorders
NauseaGastrointestinal disorders
InsomniaPsychiatric disorders
DiarrheaGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
DyspneaRespiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders
Mucositis oralGastrointestinal disorders
MyalgiaMusculoskeletal and connective tissue disorders
PainGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
BloatingGastrointestinal disorders
AnxietyPsychiatric disorders
Hot flashes/ flushesVascular disorders
ParesthesiaNervous system disorders
DysgeusiaNervous system disorders
DyspepsiaGastrointestinal disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
Pain in extremityMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
TinnitusEar and labyrinth disorders
Back painMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
Abdominal distensionGastrointestinal disorders
Other skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders
HypertensionVascular disorders
Edema limbsGeneral disorders
Pelvic painReproductive system and breast disorders
CoughRespiratory, thoracic and mediastinal disorders
Hearing impairedEar and labyrinth disorders
FlushingVascular disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
PalpitationsCardiac disorders
DepressionPsychiatric disorders
Urinary incontinenceRenal and urinary disorders
Vaginal dischargeReproductive system and breast disorders

Most-reported serious reactions: Febrile neutropenia, Infusion site extravasation, Anemia, Nausea, Abdominal pain, Neutrophil count decreased, Female genital tract fistula, Vaginal discharge.

Data from ClinicalTrials.gov NCT00993655 adverse events section.

Sponsor's own description

RATIONALE: 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. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with ovarian epithelial cancer, primary peritoneal cancer, and fallopian tube cancer. PURPOSE: This randomized phase II trial is comparing the side effects of three combination chemotherapy regimens and to see how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Publications & conference data

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

  1. 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
  2. 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
  3. Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer.
    Jaaback K, Johnson N, Lawrie TA. · · 2011 · cited 51× · PMID 22071822 · DOI 10.1002/14651858.cd005340.pub3
  4. Long-Term Survival Analysis of Intraperitoneal versus Intravenous Chemotherapy for Primary Ovarian Cancer and Comparison between Carboplatin- and Cisplatin-based Intraperitoneal Chemotherapy.
    Eoh KJ, Lee JY, Nam EJ, Kim S, et al · · 2017 · cited 10× · PMID 29115086 · DOI 10.3346/jkms.2017.32.12.2021

Verify or expand the search:

Other trials of carboplatin

Trials testing the same drug.

Other recruiting trials for Fallopian Tube Cancer

Currently open trials in the same condition.

Other Canadian Cancer Trials Group trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT00993655.

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