Trial | NCT00003382  Report issue

Title

Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    None
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.
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.
Study Started
May 31
1998
Primary Completion
Apr 30
2006
Last Update
Jun 10
2013
Estimate

Biological filgrastim

Drug gemcitabine hydrochloride

Drug topotecan hydrochloride

Criteria 

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
No Results Posted