Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: filgrastim Drug: gemcitabine hydrochloride Drug: topotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube |
| Study Start Date: | May 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Community Hospital of Los Gatos | |
| Los Gatos, California, United States, 95032 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Women's Cancer Center | |
| Palo Alto, California, United States, 94304 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at The University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Pennsylvania | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Study Chair: | Ming-teh D. Chen, MD | Women's Cancer Center - Los Gatos |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003382 History of Changes |
| Other Study ID Numbers: | CDR0000066377, GOG-9702 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Gemcitabine Topotecan Lenograstim Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013