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GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors Clinical research trials and GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors. GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors clinical trial. Participants frequently get the best healthcare available for their GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors  GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Institute for Drug Development , National Cancer Institute (NCI)
Synopsis: 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: Phase I trial to study the effectiveness of combining GTI-2040 with gemcitabine in treating patients who have metastatic or unresectablesolid tumors.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChrisTakimoto, Study Chair, Cancer Therapy and Research Center
Cancer Therapy and Research Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Chris Takimoto 210-562-1725
Additional Information:
Study ID Numbers: CDR0000353204; CTRC-IDD-0306,NCI-6090
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078962
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
2. Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
3. Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
4. Lidocaine Patch in Treating Cancer Patients with Neuropathic Pain After Surgery
5. Buspirone in Reducing Shortness of Breath in Patients With Cancer
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GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
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