Know Cancer

or
forgot password

Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Melanoma (Skin), Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Keith C. Bible, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066793

NCT ID:

NCT00003690

Start Date:

December 1998

Completion Date:

September 2003

Related Keywords:

  • Breast Cancer
  • Melanoma (Skin)
  • Prostate Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Breast Neoplasms
  • Melanoma
  • Prostatic Neoplasms
  • Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905