Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

NCT ID: NCT00002913

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-12-31

Brief Summary

Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan administered together with or without filgrastim (G-CSF) in patients with newly diagnosed advanced ovarian cancer.

II. Describe and quantitate the clinical toxic effects of combination chemotherapy with paclitaxel, cisplatin, and topotecan with or without G-CSF.

III. Assess preliminary evidence of antitumor activity of this combination chemotherapy in these patients.

OUTLINE: This is a dose escalation study of topotecan.

Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed as clinically indicated.

Conditions

Brenner Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (paclitaxel, cisplatin, topotecan hydrochloride)

Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

Given IV

cisplatin

Intervention Type: DRUG

Given IV

topotecan hydrochloride

Intervention Type: DRUG

Given IV

filgrastim

Intervention Type: BIOLOGICAL

Given SC

Interventions

paclitaxel

Given IV

Intervention Type: DRUG

cisplatin

Given IV

Intervention Type: DRUG

topotecan hydrochloride

Given IV

Intervention Type: DRUG

filgrastim

Given SC

Intervention Type: BIOLOGICAL

Other Intervention Names

Anzatax; Asotax; TAX; Taxol; CACP; CDDP; CPDD; DDP; hycamptamine; Hycamtin; SKF S-104864-A; TOPO; G-CSF; Neupogen

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed epithelial ovarian carcinoma

• No borderline ovarian carcinoma
• Stage III/IV disease that has been suboptimally or optimally debulked
• The following histologies are eligible:

• Adenocarcinoma (unspecified)
• Mucinous cystadenocarcinoma
• Clear cell adenocarcinoma
• Serous cystadenocarcinoma
• Endometrioid adenocarcinoma
• Transitional cell carcinoma
• Malignant Brenner's tumor
• Undifferentiated carcinoma
• Mixed epithelial carcinoma
• Extraovarian papillary serous cystadenocarcinoma
• Measurable or evaluable disease
• Performance status - GOG 0-1
• Enabling completion of at least 2 courses of therapy
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• No myocardial infarction within 6 months
• No congestive heart failure
• No unstable or uncontrolled angina
• No history of cardiac arrhythmia requiring anti-arrhythmia medication
• No uncontrolled hypertension
• No hypersensitivity to E. coli-derived drug preparation
• No active infection
• No sensory neuropathy
• No other malignancies within the past 5 years except nonmelanomatous skin cancer
• No prior chemotherapy
• No prior radiotherapy
• Recovered from any recent surgery

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Armstrong

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group of Arizona

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

GOG-9602

Identifier Type: -

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000065286

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02251

Identifier Type: -

Identifier Source: org_study_id