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


Phase 2
18 Years
N/A
Not Enrolling
Female
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

Thank you

Trial Information

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


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 2 hours 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 2 hours 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)

Outcome 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.

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Keith Bible

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00029

NCT ID:

NCT00083122

Start Date:

April 2004

Completion Date:

February 2012

Related Keywords:

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

Name

Location
Mayo Clinic Rochester, Minnesota  55905