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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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Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

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