Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic Identifier:
First received: November 1, 1999
Last updated: August 2, 2011
Last verified: August 2011

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid tumors.

Condition Intervention Phase
Breast Cancer
Melanoma (Skin)
Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: alvocidib
Drug: carboplatin
Drug: cisplatin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Estimated Enrollment: 48
Study Start Date: December 1998
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the maximum tolerated dose (MTD) of flavopiridol and cisplatin in patients with advanced solid tumors. (Part 1)
  • Determine the MTD of carboplatin when combined with flavopiridol in another group of patients with advanced solid tumors. (Part 2)
  • Determine the toxic effects of these regimens in this patient population.
  • Determine the objective clinical response in patients treated with this regimen.
  • Determine the pharmacokinetics of these regimens in this patient population.

OUTLINE: This is a dose-escalation study of flavopiridol and cisplatin (part 1), followed by a dose-escalation study of carboplatin (part 2).

  • Part 1: Patients receive flavopiridol IV over 24 hours. Two weeks later, patients receive cisplatin IV over 2 hours immediately followed by flavopiridol IV over 24 hours. Treatment with cisplatin/flavopiridol continues every 3 weeks in the absence of unacceptable toxicity or disease progression.

Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Cohorts of 3-6 patients receive escalating doses of flavopiridol and then cisplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

  • Part 2: Additional patients are accrued for part 2. Those patients receive carboplatin IV over 30 minutes immediately followed by flavopiridol IV over 24 hours. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the MTD is determined. The MTD is defined as in part 1.

PROJECTED ACCRUAL: Approximately 36-48 patients will be accrued for this study within 2 years.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed unresectable advanced solid tumor for which no standard therapy exists that is potentially curative or definitely capable of extending life expectancy

    • Biopsy confirmation of recurrent tumors required, unless sole site of disease is inaccessible bony and/or pulmonary metastases
  • Eligible solid tumors include, but not are limited to, prostate cancer, breast cancer, or melanoma
  • No lymphoma
  • No CNS metastases

    • Patients with primary brain tumors are eligible if they are not receiving antiepileptic medication(s) but are receiving stable doses of corticosteroids
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • See Disease Characteristics
  • At least 12 weeks


  • WBC at least 3,500/mm^3
  • Absolute neutrophil count at least 1,700/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8 g/dL


  • Bilirubin within upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • No New York Heart Association class III or IV heart disease
  • No history of angina


  • No grade 2 or greater peripheral neuropathy
  • No seizure disorder


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection


Biologic therapy:

  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent immunotherapy


  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics


  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy


  • See Disease Characteristics
  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 identifier: NCT00003690

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Keith C. Bible, MD, PhD Mayo Clinic
  More Information

Responsible Party: Keith C. Bible, M.D., Ph.D., Mayo Clinic Cancer Center Identifier: NCT00003690     History of Changes
Other Study ID Numbers: CDR0000066793  U01CA069912  P30CA015083  950101  276-97 
Study First Received: November 1, 1999
Last Updated: August 2, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
stage IV breast cancer
recurrent breast cancer
stage IV prostate cancer
recurrent prostate cancer
stage IV melanoma
recurrent melanoma
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Prostatic Neoplasms
Breast Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016