NCT01167712|Active Not RecruitingPhase 3Results

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

GOG-0262: A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865) in the Treatment of Primary Stage II, III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262

National Cancer Institute (NCI)ClinicalTrials.gov

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8 other identifiers

NCI-2011-03812GOG-0262/ACRIN 669511-00374CDR0000681448ACRIN 6695GOG-0262U10CA180868U10CA027469

Study Type

interventional

Target

692

Locations

3 countries

Sites

564

Timeline

RegisteredJul 2010

StartedSep 2010

CompletionJul 2026

Brief Summary

This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

692

participants targeted

Target at P75+ for phase_3

Timeline

2mo left

Started Sep 2010

Longer than P75 for phase_3

Geographic Reach

3 countries

564 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15.8 years study duration

Study Progress99%

Sep 2010Jul 2026

First Submitted

Initial submission to the registry

July 21, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed

2 months until next milestone

Study Start

First participant enrolled

September 27, 2010

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed

8.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2026

Expected

Last Updated

May 4, 2026

Status Verified

December 1, 2025

Enrollment Period

5.2 years

First QC Date

July 21, 2010

Results QC Date

October 2, 2017

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival
First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. 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.
The timeframe is from enrollment onto the study up to 3 years following enrollment.

Secondary Outcomes (2)

Median Duration of First Quartile Survival
The timeframe is from enrollment onto the study up to 3 years after enrollment
Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)
18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks

Other Outcomes (1)

Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product
Baseline (T0) up to 10 days after the start of course 2 (T2)

Study Arms (2)

Arm I (adjuvant chemotherapy suboptimally debulked)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

Biological: BevacizumabDrug: CarboplatinProcedure: Computed TomographyDrug: PaclitaxelProcedure: Therapeutic Conventional Surgery

Arm II (neoadjuvant chemotherapy)

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Biological: BevacizumabDrug: CarboplatinProcedure: Computed TomographyDrug: PaclitaxelProcedure: Therapeutic Conventional Surgery

Interventions

BevacizumabBIOLOGICAL

Given IV

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