Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: paclitaxel Drug: cisplatin Drug: topotecan hydrochloride Biological: filgrastim |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES |
- Maximally tolerated doses (MTDs) of the combination of paclitaxel, Topotecan, and cisplatin administered without and with G-CSF based on dose-limiting toxicities (DLT) graded according to GOG Common Toxicity Criteria [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | December 1996 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Drug: paclitaxel
Given IV
Other Names:
Drug: cisplatin
Given IV
Other Names:
Drug: topotecan hydrochloride
Given IV
Other Names:
Biological: filgrastim
Given SC
Other Names:
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002913 History of Changes |
| Other Study ID Numbers: | NCI-2012-02251, GOG-9602, U10CA027469, CDR0000065286 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cystadenocarcinoma Cystadenocarcinoma, Mucinous Cystadenocarcinoma, Serous Adenocarcinoma Adenocarcinoma, Mucinous Brenner Tumor Carcinoma Carcinoma, Endometrioid Neoplasms, Glandular and Epithelial Ovarian Neoplasms Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue |
Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Gonadal Disorders Endocrine System Diseases Endometrial Neoplasms Uterine Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Cisplatin Paclitaxel |
ClinicalTrials.gov processed this record on June 17, 2013