Carboplatin and Paclitaxel With or Without Cediranib in Treating Women With Relapsed Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer

  • STATUS
    Recruiting
  • participants needed
    2000
  • sponsor
    Medical Research Council
Updated on 7 November 2020
paclitaxel
combination chemotherapy
carboplatin
tumor cells
fallopian tube
ovarian epithelial cancer
peritoneal cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective with or without cediranib in treating relapsed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer. PURPOSE: This randomized phase III trial is studying the side effects and how well carboplatin given together with paclitaxel works compared with or without cediranib in treating women with relapsed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Description

OBJECTIVES: Primary - To determine the safety of adding cediranib once daily to standard platinum-based chemotherapy (arm A vs arms B plus C). - To investigate whether a minimal level of activity of cediranib can be detected by comparing progression-free survival (PFS) in patients receiving chemotherapy alone (arm A) with PFS in patients receiving chemotherapy and cediranib (arm B plus C). - To determine the efficacy of cediranib, in terms of overall survival (OS), in patients treated with chemotherapy alone vs concurrent cediranib and chemotherapy (arm A vs arm B) and in patients treated with chemotherapy alone vs concurrent and maintenance cediranib and chemotherapy (arm A vs arm C). - To compare the efficacy of concurrent versus concurrent plus maintenance cediranib (arm B vs arm C), in terms of OS, if the above comparisons show a significant benefit with cediranib. Secondary - To investigate whether a minimal level of activity of cediranib can be detected by comparing OS in patients receiving chemotherapy alone (arm A) with OS in patients receiving chemotherapy and cediranib (arm B plus C) and to compare toxicity between the arms. - To determine the efficacy of cediranib, in terms of PFS, in patients treated with chemotherapy alone vs concurrent cediranib and chemotherapy (arm A vs arm B) and in patients treated with chemotherapy alone vs concurrent and maintenance cediranib and chemotherapy (arm A vs arm C). - To compare the efficacy of concurrent versus concurrent plus maintenance cediranib (arm B vs arm C) in terms of PFS, if the above comparisons show a significant benefit with cediranib. - To evaluate the nature, severity, and frequency of toxicities. - To compare quality-of-life across the 3 treatment arms. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms with a 2:3:3 (arm A:arm B:arm C) ratio. - Arm A (reference): Patients receive carboplatin IV over 30-60 minutes and paclitaxel* IV over 3 hours on day 1 and an oral placebo daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral placebo alone daily for 60 weeks (until a total of 18 months after randomization). - Arm B (concurrent cediranib): Patients receive carboplatin IV and paclitaxel* IV as in arm A and oral cediranib daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive an oral placebo alone daily for 60 weeks (until a total of 18 months after randomization). - Arm C (concurrent and maintenance cediranib): Patients receive carboplatin IV and paclitaxel* IV as in arm A and oral cediranib daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral cediranib alone daily for 60 weeks (until a total of 18 months after randomization). NOTE: *If peripheral sensory or motor neuropathy ≥ grade 2 then paclitaxel can be omitted from the chemotherapy at the discretion of the treating physician After completion of study treatment, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then once a year thereafter.

Details
Condition Fallopian Tube Cancer, Ovarian Cancer
Treatment carboplatin, Paclitaxel, cediranib maleate
Clinical Study IdentifierNCT00544973
SponsorMedical Research Council
Last Modified on7 November 2020

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