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

Phase 1
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


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

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


- 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


- Creatinine no greater than 1.5 mg/dL


- No angina pectoris or clinically significant multifocal uncontrolled cardiac

- No uncontrolled hypertension


- 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


Biologic therapy:

- Not specified


- 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


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

- At least 2 weeks since limited field radiation therapy


- Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ming-teh D. Chen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Women's Cancer Center - Los Gatos


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Chao Family Comprehensive Cancer Center Orange, California  92868
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Women's Cancer Center Palo Alto, California  94304
Community Hospital of Los Gatos Los Gatos, California  95032
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009