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

Brief Title

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

Official Title

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

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.

Study Phase

Phase 1

Study Type

Interventional

Condition

Fallopian Tube Cancer

Intervention

filgrastim

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Start Date

May 1998

Primary Completion Date

April 2006

Eligibility 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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ming-teh D. Chen, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00003382

Organization ID

CDR0000066377

Secondary IDs

GOG-9702

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Ming-teh D. Chen, MD, Study Chair, Women's Cancer Center - Los Gatos

Verification Date

May 2006