Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00083122
First received: May 14, 2004
Last updated: May 6, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
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
Drug: cisplatin
Drug: alvocidib
Drug: cisplatin/flavopiridol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    Will be estimated using the method of Kaplan-Meier.

  • Time to Progression [ Time Frame: Time from registration to the date of progression or last follow-up, assessed up to 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: April 2004
Study Completion Date: May 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275
Drug: cisplatin/flavopiridol
Given IV
Experimental: 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.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275
Drug: cisplatin/flavopiridol
Given IV

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083122

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Keith Bible Mayo Clinic
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083122     History of Changes
Other Study ID Numbers: NCI-2009-00029, NCI-2009-00029, CDR0000363562, MC0261, 5876, N01CM62205, P30CA015083
Study First Received: May 14, 2004
Results First Received: March 22, 2013
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Alvocidib
Cisplatin
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014