LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Adult, Solid Tumor
In brief
RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.
Key facts
- Study ID
- NCT00052273
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 16
- Starts
- 2002-12-01
- Expected to finish
- 2005-10-01
- Last updated by the study team
- 2020-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Measurable or evaluable disease
- 18 and over
- ECOG 0-2
- Hematopoietic
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 9 g/dL (erythrocyte transfusions allowed)
- Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- Renal
- Creatinine clearance at least 50 mL/min
- Potassium at least 3.4 mEq/L
- Calcium at least 8.4 mg/dL
- Magnesium at least 1.2 mEq/L
- Cardiovascular
- QTc interval no greater than 450 msec in males
- QTc interval no greater than 470 msec in females
- No other electrocardiogram abnormalities
- Able to swallow capsules
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3-6 months after study
- Endocrine therapy
- At least 4 weeks since prior anticancer hormonal therapy
You may not qualify if…
- known untreated or symptomatic CNS metastases
- concurrent hematologic malignancies
- gastrointestinal disorder that would interfere with oral drug absorption
- serious concurrent systemic disorder
- compliance issues that would preclude study
- geographical conditions that would preclude study
- active infection
- prior hypersensitivity to any component of study drugs
- pregnant or nursing
- concurrent immunotherapy
- concurrent routine filgrastim (G-CSF)
- other concurrent chemotherapy
- other concurrent hormonal therapy
- concurrent radiotherapy (including palliative therapy)
- other concurrent experimental medications
- other concurrent anticancer therapy
Where it is running
- Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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