Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas
cisplatin
+ alvocidib
+ cisplatin/flavopiridol
Abdominal Neoplasms+24
+ Carcinoma, Ovarian Epithelial
+ Urogenital Diseases
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol. II. Determine the toxicity of this regimen in these patients. 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: 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. GROUP 2 (Closed to accrual as of 3/10/06): 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. Patients are followed every 3 months for up to 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically confirmed ovarian epithelial or primary peritoneal cancer: Advanced disease * Meets at least 1 of the following criteria: * Measurable disease; * Evaluable disease plus CA 125 \>= 2 times post-treatment nadir * Treated with 1, and only 1, prior platin-containing chemotherapy regimen (e.g., paclitaxel or carboplatin-based) for ovarian epithelial or primary peritoneal cancer * Prior treatment with the same regimen at first relapse allowed; * No more than 3 total chemotherapy regimens allowed provided exactly 1 has been platin-containing; * Must also have platin-resistant disease as defined for Group 1; * Rechallenge with a single regimen upon progression after a hiatus from therapy counts as a single regimen * Group 1, meeting 1 of the following criteria: * Patients who relapse during or \< 6 months after completion of post-debulking chemotherapy; * "Platinum sensitive" patients in second relapse after having been treated/rechallenged with their initial regimen upon first relapse * Group 2 (Closed to accrual as of 3/10/06): * Patients who relapse \>= 6 months after completion of post-debulking chemotherapy and are not retreated with the same or a different regimen * No CNS metastases * Performance status: * ECOG 0-2 * Hematopoietic: * Absolute neutrophil count \>= 1,500/mm3; * Platelet count \>= 100,000/mm3; * Hemoglobin \>= 10 g/dL (Note: May be supported with transfusion, epoetin alfa, or darbepoetin alfa) * Hepatic: * AST =\< 2.5 times upper limit of normal (ULN); * Alkaline phosphatase =\< 2.5 times ULN; * Bilirubin =\< 1.5 times ULN * Renal: * Creatinine =\< 1.5 times ULN * Cardiovascular: * No cardiac arrhythmia; * No cardiac failure * Not pregnant or nursing * Negative pregnancy test * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * More than 3 weeks since prior radiotherapy * Recovered from all prior therapy * Fertile patients must use effective contraception * No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix * No diabetes * No peripheral neuropathy \>= grade 2 * No baseline diarrhea (\>= 4 stools/day) * No uncontrolled infection * No other concurrent uncontrolled serious medical condition * No concurrent routine colony-stimulating factors
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location