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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083122 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin and flavopiridol, work in 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: This phase II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: alvocidib Drug: cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial Of Flavopiridol And Cisplatin In Advanced Epithelial Ovarian And Primary Peritoneal Carcinomas |
Estimated Enrollment: | 79 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Experimental
Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: alvocidib
Given IV
Drug: cisplatin
Given IV
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Group 2: Experimental
Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Drug: alvocidib
Given IV
Drug: cisplatin
Given IV
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OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are accrued to two separate groups (Group 2 closed to accrual as of 3/10/06).
Group 1
Group 2
Patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A total of 38-79 patients (20-42 for group 1 and 18-37 for group 2 [Closed to accrual as of 3/10/06]) will be accrued for this study within 7-14 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal cancer
Meets at least 1 of the following criteria:
Treated with 1, and only 1, prior chemotherapy regimen (e.g., paclitaxel or carboplatin-based) for ovarian epithelial or primary peritoneal cancer
Group 1, meeting 1 of the following criteria:
Group 2 (Closed to accrual as of 3/10/06)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, District of Columbia | |
Howard University Cancer Center | Recruiting |
Washington, District of Columbia, United States, 20060 | |
Contact: Clinical Trials Office - Howard University Cancer Center 202-806-9122 | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Paula M. Fracasso, MD, PhD 314-454-8817 |
Study Chair: | Keith C. Bible, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000363562, MAYO-MC0261, NCI-5876 |
Study First Received: | May 14, 2004 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00083122 |
Health Authority: | Unspecified |
recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Dental Caries |
Recurrence Carcinoma Genital Diseases, Female Flavopiridol Digestive System Diseases Cisplatin Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors |