search
Back to results

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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filgrastim
gemcitabine hydrochloride
topotecan hydrochloride
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Community Hospital of Los Gatos
  • Chao Family Comprehensive Cancer Center
  • Women's Cancer Center
  • University of Chicago Cancer Research Center
  • Holden Comprehensive Cancer Center at The University of Iowa
  • University of Pennsylvania Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 7, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003382
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Terminated
Study Start Date
May 1998 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-teh D. Chen, MD
Organizational Affiliation
Women's Cancer Center - Los Gatos
Official's Role
Study Chair
Facility Information:
Facility Name
Community Hospital of Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Women's Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16150481
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs