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Oxaliplatin and Topotecan in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

2014-08-27 03:45:15 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and topotecan, 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) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Description

OBJECTIVES:

Primary

- Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan.

- Determine the toxic effects in patients treated with this regimen.

Secondary

- Estimate the time to progression and overall clinical response duration in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients are stratified according to response to prior platinum therapy (resistant vs sensitive).

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Fallopian Tube Cancer

Intervention

oxaliplatin, topotecan hydrochloride

Location

Beth Israel Deaconess Medical Center
Boston
Massachusetts
United States
02215

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:15-0400

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Medical and Biotech [MESH] Definitions

Diseases involving the FALLOPIAN TUBES including neoplasms (FALLOPIAN TUBE NEOPLASMS); SALPINGITIS; tubo-ovarian abscess; and blockage.

Methods for assessing the patency of the fallopian tubes.

Benign or malignant neoplasms of the FALLOPIAN TUBES. They are uncommon. If they develop, they may be located in the wall or within the lumen as a growth attached to the wall by a stalk.

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

Formation of an artificial opening in a fallopian tube.

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