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An Open-Label, Non-Randomized Phase I Study of the Protein Kinase C Inhibitor Flavopiridol Administered in Combination With Paclitaxel 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

An Open-Label, Non-Randomized Phase I Study of the Protein Kinase C Inhibitor Flavopiridol Administered in Combination With Paclitaxel in Patients With Advanced Solid Tumors


OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol when administered in
combination with paclitaxel and cisplatin in patients with refractory adult solid tumors.
II. Investigate the clinical pharmacokinetics of intravenous flavopiridol when administered
in combination with paclitaxel in these patients. III. Obtain preliminary data on the
therapeutic activity of flavopiridol when administered in combination with paclitaxel in
these patients. IV. Evaluate surrogate markers of activity such as inhibition of PKC or CDK1
in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive paclitaxel IV over 3
hours on day 1. On day 2, patients receive cisplatin IV over 20 minutes followed by a 24
hour infusion of flavopiridol. Courses are repeated every 21 days in the absence of disease
progression or unacceptable toxicity. Sequential dose escalation of flavopiridol is followed
by sequential dose escalation of cisplatin. Dose escalation in cohorts of 3-6 patients each
continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are
followed every 6 weeks.

PROJECTED ACCRUAL: Approximately 46-73 patients will be accrued for this study within 6 more
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven solid tumors that are refractory or
recurrent -No CNS primary or metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky at least 60%
Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and
ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5
mg/dL Cardiovascular: At least 6 months since prior cardiac arrhythmias, myocardial
infarction, or congestive heart failure Other: Not pregnant or nursing Effective
contraceptive method must be used for 2 months after study completion Not HIV positive No
uncontrolled or serious infection No pre-existing grade 3 or greater neurotoxicity Must be
mentally capable of understanding the explanation of the 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) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy Surgery: Not specified Other: No presence of toxic effects from prior therapy

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:

96-077

NCT ID:

NCT00003004

Start Date:

July 1997

Completion Date:

October 2001

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