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Status:

COMPLETED

Gemcitabine Hydrochloride and Alvocidib in Treating Patients With Solid Tumors

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This phase I trial is studying the side effects and best dose of gemcitabine hydrochloride and alvocidib in treating patients with solid tumors. Drugs used in chemotherapy, such as gemcitabine hydroch...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with solid tumors. SECONDARY OBJECTIVES: I. Determine the safety profile and toxic effects of...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No severe malnutrition
  • No more than 2 prior chemotherapy regimens:
  • Prior combined modality therapy (e.g., full-dose chemotherapy with radiosensitizing chemotherapy and radiotherapy) is considered 1 prior regimen if all therapy was delivered as part of 1 comprehensive treatment plan
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy
  • At least 6 months since prior radiotherapy to the lung parenchyma or mediastinum and no evidence of radiation pneumonitis on chest CT scan
  • At least 4 weeks since other prior radiotherapy and recovered
  • No prior radiotherapy to more than 50% of marrow volume
  • No concurrent radiotherapy
  • Histologically confirmed solid tumor for which gemcitabine is a treatment option OR for which no efficacious therapy exists
  • Must meet criteria for 1 of the following:
  • Measurable disease:
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Nonmeasurable disease, including any of the following:
  • Small lesions (less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan)
  • Bone lesions
  • Cytologically positive pleural or peritoneal disease
  • Elevated tumor markers (e.g., carcinoembryonic antigen, CA 125, CA 19-9, or other tumor marker)
  • Multinodular or confluent nonmeasurable pulmonary, hepatic, adrenal, intra-abdominal, or skin metastases
  • No active CNS metastases
  • Previously treated CNS metastases must be stable with no symptoms for 4 weeks after completion of treatment AND patient must be off steroid therapy or on a stable dose for at least the past 2 weeks
  • No known leptomeningeal metastases
  • Performance status:
  • ECOG 0-1
  • Hematopoietic:
  • Absolute neutrophil count at least 1,500/mm3;
  • Platelet count at least 100,000/mm3
  • Hepatic:
  • Bilirubin no greater than 1.5 mg/dL;
  • SGOT no greater than 2.5 times upper limit of normal
  • Renal:
  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min
  • Cardiovascular:
  • None of the following within the past 6 months:
  • Myocardial infarction;
  • Unstable angina;
  • Transient ischemic attack;
  • Cerebrovascular accident
  • No new cardiac arrhythmia possibly related to cardiac ischemia;
  • No large and potentially symptomatic pericardial effusion;
  • No cardiac disease that would preclude study participation
  • Pulmonary:
  • No pulmonary embolism within the past 6 months;
  • No large and potentially symptomatic pleural effusion;
  • No pulmonary disease that would preclude study participation
  • Gastrointestinal:
  • No intractable emesis;
  • No grade 2 or greater chronic diarrheal disease within the past 6 months
  • Not pregnant or nursing

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    58 Patients enrolled

    Trial Details

    Trial ID

    NCT00072436

    Start Date

    September 1 2003

    Last Update

    July 2 2013

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, United States, 02114

    2

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    3

    Memorial Sloan Kettering Cancer Center

    New York, New York, United States, 10065