- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002913
Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
Study Overview
Status
Conditions
- Ovarian Clear Cell Cystadenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Serous Cystadenocarcinoma
- Stage IV Ovarian Epithelial Cancer
- Brenner Tumor
- Stage III Ovarian Epithelial Cancer
- Ovarian Mucinous Cystadenocarcinoma
- Ovarian Mixed Epithelial Carcinoma
- Ovarian Undifferentiated Adenocarcinoma
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85012
- Gynecologic Oncology Group of Arizona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Given IV
Other Names:
Given SC
Other Names:
Given IV
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Up to 10 years
|
Up to 10 years
|
Progression-free survival
Time Frame: Up to 10 years
|
Up to 10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Deborah Armstrong, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Neoplasms, Connective Tissue
- Neoplasms, Cystic, Mucinous, and Serous
- Ovarian Neoplasms
- Endometrial Neoplasms
- Neoplasms, Fibrous Tissue
- Neoplasms, Fibroepithelial
- Carcinoma
- Adenocarcinoma
- Carcinoma, Ovarian Epithelial
- Cystadenocarcinoma, Serous
- Carcinoma, Endometrioid
- Cystadenocarcinoma
- Cystadenocarcinoma, Mucinous
- Brenner Tumor
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Paclitaxel
- Cisplatin
- Topotecan
Other Study ID Numbers
- NCI-2012-02251
- U10CA027469 (U.S. NIH Grant/Contract)
- GOG-9602
- CDR0000065286 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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