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

Recurrent Ovarian Epithelial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083122
• Other study ID #: NCI-2009-00029
• Secondary ID: NCI-2009-00029CD
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2004
• Last updated: May 6, 2014
• Start date: April 2004
• Est. completion date: May 2012

Study information

• Verified date: April 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Neoplasms
• 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

Intervention

Drug:
• cisplatin
Given IV
• alvocidib
Given IV
• cisplatin/flavopiridol
Given IV

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)	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	No
Secondary	Overall Survival	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	No
Secondary	Time to Progression	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	No