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UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

2014-08-27 03:54:47 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Description

OBJECTIVES:

Primary

- Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Secondary

- Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.

- Determine the progression-free, median, and overall survival of patients treated with this regimen.

- Determine the safety and tolerability of this regimen in these patients.

- Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Fallopian Tube Cancer

Intervention

7-hydroxystaurosporine, topotecan hydrochloride

Location

Margaret and Charles Juravinski Cancer Centre
Hamilton
Ontario
Canada
L8V 5C2

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:47-0400

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The effects of hydrocortisone on tight junction genes in an in vitro model of the human fallopian epithelial cells.

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Higher Prevalence of Endometrial Polyps in Patients with Fallopian Tube Obstruction: A Case-Control Study.

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Port-site metastasis as a primary complication following diagnostic laparoscopy of fallopian tube carcinoma: A case report.

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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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