GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
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
Key facts
- Study ID
- NCT00078962
- Run by
- National Cancer Institute (NCI)
- People needed
- 40
- Starts
- 2004-01-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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