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

Primary Purpose

Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IIIA Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
alvocidib
cisplatin/flavopiridol
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Ovarian Epithelial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival
Will be estimated using the method of Kaplan-Meier.
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.

Full Information

First Posted
May 14, 2004
Last Updated
May 6, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00083122
Brief Title
Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official Title
Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
alvocidib
Other Intervention Name(s)
FLAVO, flavopiridol, HMR 1275, L-868275
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cisplatin/flavopiridol
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years
Title
Time to Progression
Description
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 Frame
Time from registration to the date of progression or last follow-up, assessed up to 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Bible
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22664059
Citation
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.
Results Reference
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Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer

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