Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	NCI	MAYO-MC0261 5876, NCI-5876, NCT00083122

Special Category: NCI Web site featured trial

Objectives

1. Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol.
2. Determine the toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

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

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

Expected Enrollment

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.

Outcomes

Tumor response (complete or partial) on 2 consecutive evaluations at least 4-6 weeks apart

Overall survival
Time to progression

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.

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Keith Bible, MD, PhD, Protocol chair		Ph: 507-284-2511 Email: bible.keith@mayo.edu

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
District of Columbia
	Washington
	Howard University Cancer Center
		Clinical Trials Office - Howard University Cancer Center	Ph:  202-806-9122
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
Michigan
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Paula Fracasso, MD, PhD	Ph:  314-454-8817 800-600-3606

Related Information

Featured trial article

Registry Information
Official Title		Phase II Trial Of Flavopiridol And Cisplatin In Advanced Epithelial Ovarian And Primary Peritoneal Carcinomas
Trial Start Date		2004-04-20
Trial Completion Date		2005-11-26 (estimated)
Registered in ClinicalTrials.gov		NCT00083122
Date Submitted to PDQ		2004-03-18
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CM17104, CA15083

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