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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00003690
First received: November 1, 1999
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • See Disease Characteristics
  • At least 12 weeks

Hematopoietic:

  • 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

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

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

Neurologic:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

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

Surgery:

  • 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 ClinicalTrials.gov identifier: NCT00003690

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Keith C. Bible, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Keith C. Bible, M.D., Ph.D., Mayo Clinic Cancer Center
ClinicalTrials.gov 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:
Breast Neoplasms
Melanoma
Prostatic Neoplasms
Breast Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Prostatic Diseases
Skin Diseases
Urogenital Neoplasms
Carboplatin
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014