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Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers


OBJECTIVES:

- Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol
and docetaxel in patients with advanced solid tumors.

- Determine the objective response rate and duration of response in patients treated with
this regimen.

- Determine the pharmacokinetics of these drugs in this patient population.

OUTLINE: This is a dose-escalation study.

Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over
24 hours on day 2. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 9-11
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic or unresectable solid tumor

- No standard relatively effective curative or palliative measures exist

- Measurable disease in at least 1 dimension

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- No known clinically active and uncontrolled brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

- Karnofsky 60-100%

Life expectancy:

- More than 12 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal

- ALT/AST no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine normal

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other:

- No prior allergic reactions to compounds of similar chemical or biologic composition
to flavopiridol or docetaxel

- No other uncontrolled concurrent illness that would preclude study participation

- No ongoing or active infection

- No psychiatric illness or social situations that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- At least 6 months since prior taxane therapy

- At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or
mitomycin) and recovered

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except contraceptives, appetite stimulants, or
replacement steroids

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Philip A. Philip, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068605

NCT ID:

NCT00016185

Start Date:

March 2001

Completion Date:

December 2005

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201