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

NCT ID: NCT00003382

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31

Brief 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.

Detailed 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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

gemcitabine hydrochloride

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Ming-teh D. Chen, MD

Role: STUDY_CHAIR

Women's Cancer Center - Los Gatos

Locations

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 Chicago Cancer Research Center

Chicago, Illinois, United States

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

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. doi: 10.1016/j.ygyno.2005.07.114. Epub 2005 Sep 8.

Reference Type: RESULT

PMID: 16150481 (View on PubMed)

Other Identifiers

GOG-9702

Identifier Type: -

Identifier Source: secondary_id

CDR0000066377

Identifier Type: -

Identifier Source: org_study_id