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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003382
First received: November 1, 1999
Last updated: June 7, 2013
Last verified: May 2006

November 1, 1999
June 7, 2013
May 1998
April 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003382 on ClinicalTrials.gov Archive Site
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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

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Biological: filgrastim
  • Drug: gemcitabine hydrochloride
  • Drug: topotecan hydrochloride
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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April 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003382
CDR0000066377, GOG-9702
Not Provided
Not Provided
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Ming-teh D. Chen, MD Women's Cancer Center - Los Gatos
Gynecologic Oncology Group
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP