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Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study is currently recruiting participants.
Study NCT00083122   Information provided by National Cancer Institute (NCI)
First Received: May 14, 2004   Last Updated: July 7, 2009   History of Changes

May 14, 2004
July 7, 2009
April 2004
November 2005   (final data collection date for primary outcome measure)
Tumor response (complete or partial) on 2 consecutive evaluations at least 4-6 weeks apart [ Designated as safety issue: No ]
Tumor response (complete or partial) on 2 consecutive evaluations at least 4-6 weeks apart
Complete list of historical versions of study NCT00083122 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival
  • Time to progression
 
Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Phase II Trial Of Flavopiridol And Cisplatin In Advanced Epithelial Ovarian And Primary Peritoneal Carcinomas

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Drug: alvocidib
  • Drug: cisplatin
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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
79
 
November 2005   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
 
United States
 
NCT00083122
Charles Erlichman, Mayo Clinic Cancer Center
CDR0000363562, MAYO-MC0261, NCI-5876
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Keith C. Bible, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP