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Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, Peritoneal Cancer, or Recurrent Triple-Negative Breast Cancer

2014-08-27 03:13:59 | BioPortfolio

Summary

RATIONALE: Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving cediranib maleate together with olaparib may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and the best dose of cediranib maleate when given together with olaparib and to see how well they work compared to cediranib maleate alone in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cancer, or recurrent triple-negative breast cancer.

Description

OBJECTIVES:

Primary

- Assess the maximum-tolerated dose of cediranib maleate in combination with olaparib in patients with recurrent platinum-sensitive papillary-serous ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer. (Phase I)

- Assess the efficacy, in terms of progression-free survival (PFS), of cediranib maleate with versus without olaparib in patients with recurrent grade 2 or 3 platinum-sensitive papillary-serous ovarian, fallopian tube, or peritoneal cancer. (Phase II)

Secondary

- Assess the toxicity of this regimen in these patients. (Phase I)

- Assess the clinical benefit, PFS, and overall survival of patients treated with this regimen. (Phase I)

- Assess tumor response, clinical response benefit, and overall survival of patients treated with these regimens. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a randomized phase II study.

- Phase I: Patients receive oral cediranib maleate once daily and oral olaparib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

- Phase II: Patients are stratified according to prior antiangiogenic therapy (yes vs no) and BRCA mutation status (carrier vs non-carrier vs unknown). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral cediranib maleate once daily on days 1-28.

- Arm II: Patients receive oral cediranib maleate once daily and oral olaparib twice daily on days 1-28.

In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

cediranib maleate, olaparib

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

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