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Phase I Evaluation Of Carboplatin And Gemcitabine


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

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Trial Information

Phase I Evaluation Of Carboplatin And Gemcitabine


OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and carboplatin in
patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this
regimen in these patients. III. Evaluate the pharmacokinetics and pharmacodynamics of this
regimen in these patients. IV. Determine the observed responses in these patients receiving
this regimen.

OUTLINE: This is a dose-escalation study of gemcitabine. Patients are stratified according
to prior therapy (no prior chemotherapy and/or prior radiotherapy to less than 20% of bone
marrow vs prior chemotherapy and/or prior radiotherapy to at least 20% of bone marrow).
Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes
on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of gemcitabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 patients experience dose-limiting toxicity. Patients are followed for
survival.

PROJECTED ACCRUAL: A maximum of 18 patients (9 per stratum) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor for which no
standard therapy exists No untreated brain metastases with evidence of neurologic
deterioration or CNS progression

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
More than 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater
than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No
serious concurrent infection No other serious concurrent medical illness that would
preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception during and for at least 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2
prior systemic chemotherapy regimens for advanced disease Prior adjuvant or induction
therapy for initial disease allowed At least 4 weeks since prior chemotherapy (6 weeks for
nitrosoureas, mitomycin, or melphalan) No prior combination carboplatin and gemcitabine
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 30% of
bone marrow At least 4 weeks since prior radiotherapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068771

NCT ID:

NCT00021346

Start Date:

November 1997

Completion Date:

March 2002

Related Keywords:

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

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111