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Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study has been completed.

First Received on May 14, 2004.   Last Updated on May 17, 2011   History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083122
  Purpose

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
Primary Peritoneal Cavity Cancer
Drug: alvocidib
Drug: cisplatin
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Flavopiridol And Cisplatin In Advanced Epithelial Ovarian And Primary Peritoneal Carcinomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response (complete or partial) on 2 consecutive evaluations at least 4-6 weeks apart [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 79
Study Start Date: April 2004
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: cisplatin
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
Drug: cisplatin
Given IV

Detailed Description:

OBJECTIVES:

  • Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol.
  • 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

    • 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • 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

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent routine colony-stimulating factors

Chemotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 3 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083122

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, District of Columbia
Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Keith C. Bible, MD, PhD Mayo Clinic
  More Information

Additional Information:
Publications:
Peethambaram PP, Burton JK, Oberg AL, et al.: A phase 2 trial of flavopiridol and cisplatin in platinum-resistant ovarian cancer. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-140, 2007.

Responsible Party: Charles Erlichman, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00083122     History of Changes
Other Study ID Numbers: CDR0000363562, MAYO-MC0261, NCI-5876
Study First Received: May 14, 2004
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Flavopiridol
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Growth Inhibitors
Growth Substances
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012