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A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors


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

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Trial Information

A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors


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 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of GTI-2040 and gemcitabine hydrochloride, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0

Outcome Time Frame:

Up to day 28

Safety Issue:

Yes

Principal Investigator

Chris Takimoto

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02577

NCT ID:

NCT00078962

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

Cancer Therapy and Research Center at The UT Health Science Center at San AntonioSan Antonio, Texas  78229