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

NCT ID: NCT00083122

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2012-05-31

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Given IV

alvocidib

Intervention Type: DRUG

Given IV

cisplatin/flavopiridol

Intervention Type: DRUG

Given IV

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.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Given IV

alvocidib

Intervention Type: DRUG

Given IV

cisplatin/flavopiridol

Intervention Type: DRUG

Given IV

Interventions

cisplatin

Given IV

Intervention Type: DRUG

alvocidib

Given IV

Intervention Type: DRUG

cisplatin/flavopiridol

Given IV

Intervention Type: DRUG

Other Intervention Names

CACP; CDDP; CPDD; DDP; FLAVO; flavopiridol; HMR 1275; L-868275

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Bible

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Bible KC, Peethambaram PP, Oberg AL, Maples W, Groteluschen DL, Boente M, Burton JK, Gomez Dahl LC, Tibodeau JD, Isham CR, Maguire JL, Shridhar V, Kukla AK, Voll KJ, Mauer MJ, Colevas AD, Wright J, Doyle LA, Erlichman C; Mayo Phase 2 Consortium (P2C); North Central Cancer Treatment Group (NCCTG). A phase 2 trial of flavopiridol (Alvocidib) and cisplatin in platin-resistant ovarian and primary peritoneal carcinoma: MC0261. Gynecol Oncol. 2012 Oct;127(1):55-62. doi: 10.1016/j.ygyno.2012.05.030. Epub 2012 Jun 1.

Reference Type: DERIVED

PMID: 22664059 (View on PubMed)

Other Identifiers

NCI-2009-00029

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000363562

Identifier Type: -

Identifier Source: secondary_id

MC0261

Identifier Type: OTHER

Identifier Source: secondary_id

5876

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62205

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00029

Identifier Type: -

Identifier Source: org_study_id