A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors
GTI-2040
+ gemcitabine hydrochloride
+ laboratory biomarker analysis
Neoplasms
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, United StatesSee the location