Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer

Ovarian Cancer Clinical Trial

Official title:

A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003382
• Other study ID #: CDR0000066377
• Secondary ID: GOG-9702
• Status: Terminated
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: June 7, 2013
• Start date: May 1998

Study information

• Verified date: May 2006
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of gemcitabine and topotecan in treating patients with refractory or recurrent ovarian or fallopian tube cancer.

Description:

OBJECTIVES:

• Determine the maximum tolerated doses of the combination of gemcitabine and topotecan administered with and without filgrastim (G-CSF) in patients with refractory ovarian or fallopian tube cancer.

• Describe and quantitate the clinical toxicities of these regimens in this patient population.

OUTLINE: This is a dose escalation study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and topotecan IV over 30 minutes on days 2-4. Some patients receive filgrastim (G-CSF) subcutaneously on days 9-14. Treatment repeats every 28 days for up to 5-10 courses.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicity (DLT). Dose escalation of gemcitabine then continues in cohorts of 3-6 patients until the MTD is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience DLT.

Patients are followed every 2-3 months for 2 years, every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer

• No borderline ovarian cancer

• Extra-ovarian papillary serous tumors eligible

• Must not be eligible for any higher priority phase II or III GOG protocol

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• SGOT no greater than 3 times upper limit of normal (ULN)

• Bilirubin no greater than 1.5 mg/dL

• Elevated levels of alkaline phosphatase allowed

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias

• No uncontrolled hypertension

Other:

• No other active malignancy

• No prior malignancy within the past 5 years except nonmelanomatous skin cancer

• No active infection

• No underlying medical problem that would prevent compliance

• No known hypersensitivity to E. coli-derived drug preparations

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Must have received at least 1 prior platinum- and paclitaxel-based regimen

• At least 4 weeks since prior chemotherapy

• No prior topotecan and/or gemcitabine

• No prior chemotherapy for a different prior malignancy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to more than 10% of bone marrow

• At least 2 weeks since limited field radiation therapy

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Biological:
• filgrastim

Drug:
• gemcitabine hydrochloride

• topotecan hydrochloride

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Women's Cancer Center	Palo Alto	California
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen MD, Fleming GF, Mitchell S, Horowitz I. A phase I trial of gemcitabine and topotecan in previously treated ovarian or peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jan;100(1):111-5. Epub 2005 Sep 8. — View Citation