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

May 6, 2014 updated by: National Cancer Institute (NCI)

Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275
Drug: cisplatin
Given IV
Other Names:
  • CDDP
  • DDP
  • CACP
  • CPDD
Drug: cisplatin/flavopiridol
Given IV
Experimental: Group 2
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
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275
Drug: cisplatin
Given IV
Other Names:
  • CDDP
  • DDP
  • CACP
  • CPDD
Drug: cisplatin/flavopiridol
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)
Time Frame: 24 weeks

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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years
Will be estimated using the method of Kaplan-Meier.
Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years
Time to Progression
Time Frame: Time from registration to the date of progression or last follow-up, assessed up to 3 years
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.
Time from registration to the date of progression or last follow-up, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Keith Bible, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 14, 2004

First Posted (Estimate)

May 17, 2004

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-00029 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P30CA015083 (U.S. NIH Grant/Contract)
  • N01CM62205 (U.S. NIH Grant/Contract)
  • 5876 (Other Identifier: CTEP)
  • CDR0000363562
  • MC0261 (Other Identifier: Mayo Clinic)

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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