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GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
This study has been completed.

First Received on March 8, 2004.   Last Updated on 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: Masking: Open Label
Primary Purpose: Treatment
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

ClinicalTrials.gov Identifier: NCT00078962     History of Changes
Other Study ID Numbers: CDR0000353204, CTRC-IDD-0306, NCI-6090
Study First Received: March 8, 2004
Last Updated: February 6, 2009
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:
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012