GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gemcitabine

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