Clinical trial NCT00003382: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: 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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-07-15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Community Hospital of Los Gatos
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Women's Cancer Center
state: California
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at The University of Iowa
state: Iowa
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
Study officials:
affiliation: Women's Cancer Center - Los Gatos
name: Ming-teh D. Chen, MD
role: STUDY_CHAIR
References:
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.