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Status:

COMPLETED

GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable 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 GTI-2040 and gemcitabine in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as gemcita...

Detailed Description

OBJECTIVES: Primary I. Determine the toxicity profile and maximum tolerated dose of GTI-2040 and gemcitabine in patients with metastatic or unresectable solid tumors. Secondary I. Determine the pharm...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed solid tumor
  • Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective
  • Measurable or evaluable disease
  • No known active or progressive brain metastases or primary brain tumors
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 12 weeks
  • Hemoglobin \> 9 g/dL
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other condition (e.g., dementia or developmental delay) that would preclude giving informed consent
  • No other concurrent uncontrolled illness that would preclude study participation
  • Prior biologic therapy allowed
  • No concurrent biologic therapy
  • No concurrent immunotherapy
  • No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Prior gemcitabine allowed
  • Prior investigational chemotherapy allowed
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, carmustine, or nitrosoureas) and recovered
  • No other concurrent chemotherapy
  • Concurrent hormonal therapy (e.g., luteinizing hormone-releasing hormone agonists) for prostate cancer is allowed
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy
  • Recovered from prior surgery
  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent long-term oral anticoagulation therapy (e.g., warfarin)
  • Prophylactic warfarin to maintain central venous access patency allowed

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00078962

    Start Date

    January 1 2004

    Last Update

    January 24 2013

    Active Locations (1)

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    Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

    San Antonio, Texas, United States, 78229