Completed

Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer

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What is being tested

cisplatin

+ alvocidib
+ cisplatin/flavopiridol
Drug
Who is being recruted

Recurrent Ovarian Epithelial Cancer
+7

+ Recurrent Primary Peritoneal Cavity Cancer
+ Stage IIIA Ovarian Epithelial Cancer
Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: May 21, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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. 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. 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.

Official TitlePhase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas 
Principal SponsorNational Cancer Institute (NCI)
Last updated: May 21, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
45 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
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.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
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.
Study Objectives
Primary Objectives

A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart.
Secondary Objectives

Will be estimated using the method of Kaplan-Meier.

Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

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
Suspended
Mayo ClinicRochester, United StatesSee the location
CompletedOne Study Center