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Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors


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

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Trial Information

Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors


OBJECTIVES:

- Determine the maximum tolerated dose of flavopiridol when administered in combination
with 2 different doses of docetaxel in patients with advanced solid tumors.

- Determine the clinical pharmacokinetics of this regimen in these patients.

- Determine, preliminarily, the therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of flavopiridol.

Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by
flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are
determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10
patients are treated at each flavopiridol MTD.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced solid tumor that is refractory to standard therapy
or for which no standard therapy exists

- Measurable or evaluable disease

- No symptomatic or untreated CNS metastases or primary CNS neoplasm

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- WBC at least 3,500/mm3

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 8 g/dL

Hepatic

- Bilirubin no greater than upper limit of normal (ULN)

- SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN
OR

- Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN

Renal

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- No history of cardiac arrhythmias

- No congestive heart failure

- No myocardial infarction within the past 6 months

Other

- No concurrent serious or uncontrolled infection

- No diabetes not adequately controlled with medication

- No peripheral neuropathy greater than grade 1

- No known allergy to docetaxel or other medications formulated in Polysorbate 80

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior immunotherapy

Chemotherapy

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

- Prior taxanes allowed

- No prior flavopiridol

Endocrine therapy

- At least 4 weeks since prior hormonal therapy

Radiotherapy

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- Recovered from prior therapy

- No prior enrollment in this study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary K. Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

AVENTIS-HMR1275A/1501

NCT ID:

NCT00045448

Start Date:

April 2002

Completion Date:

December 2009

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021