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

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ClinicalTrials.gov Identifier: NCT00083122
Recruitment Status : Completed
First Posted : May 17, 2004
Results First Posted : May 14, 2013
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas
Study Start Date : April 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) [ Time Frame: 24 weeks ]

    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 :
  1. Overall Survival [ Time Frame: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years ]
    Will be estimated using the method of Kaplan-Meier.

  2. Time to Progression [ Time Frame: Time from registration to the date of progression or last follow-up, assessed up to 3 years ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083122


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Keith Bible Mayo Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083122    
Other Study ID Numbers: NCI-2009-00029
NCI-2009-00029 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000363562
MC0261 ( Other Identifier: Mayo Clinic )
5876 ( Other Identifier: CTEP )
N01CM62205 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2004    Key Record Dates
Results First Posted: May 14, 2013
Last Update Posted: May 21, 2014
Last Verified: April 2013
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Peritoneal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
 Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Cisplatin
Alvocidib
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action