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GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
This study has been completed.
First Received: March 8, 2004   Last Updated: February 6, 2009   History of Changes
Sponsor: Institute for Drug Development
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00078962
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by making tumor cells more sensitive to gemcitabine.

PURPOSE: 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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: GTI-2040
Drug: gemcitabine hydrochloride
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: January 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the toxicity profile and maximum tolerated dose of GTI-2040 and gemcitabine in patients with metastatic or unresectable solid tumors.

Secondary

  • Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive GTI-2040 IV continuously on days 2-16 of course 1 and on days 1-16 of all subsequent courses and gemcitabine IV over 30 minutes on days 1, 8, and 15 of course 1 and on days 2, 9, and 16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of GTI-2040 and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose.

PROJECTED ACCRUAL: Approximately 18-40 patients will be accrued for this study within 6-20 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Hemoglobin > 9 g/dL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (5 times ULN if hepatic metastases are present)

Renal

  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • 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 CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed
  • No concurrent biologic therapy
  • No concurrent immunotherapy
  • No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • 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

Endocrine therapy

  • Concurrent hormonal therapy (e.g., luteinizing hormone-releasing hormone agonists) for prostate cancer is allowed

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078962

Locations
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Institute for Drug Development
Investigators
Study Chair: Chris H. Takimoto, MD, PhD, FACP Cancer Therapy and Research Center, Texas
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000353204, CTRC-IDD-0306, NCI-6090
Study First Received: March 8, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00078962     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine

ClinicalTrials.gov processed this record on November 27, 2009