Status:
COMPLETED
Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemot...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors. * Determine the dose-limiting toxicity and recommended ph...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumor for which standard curative or palliative measures do not exist or are no longer effective
- Metastatic or unresectable disease
- No known brain metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- More than 12 weeks
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8.0 g/dL
- Hepatic
- AST and ALT ≤ 2.0 times upper limit of normal (ULN) AND alkaline phosphatase \[AP\] \< ULN OR
- AP ≤ 4 times ULN AND AST and ALT \< ULN
- Bilirubin normal
- Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 60 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
- Able to ingest oral medications
- No allergy attributed to study drugs, compounds of similar chemical or biological composition, drugs formulated in polysorbate 80, or other agents used in this study
- No inner ear auditory toxicity ≥ grade 2
- No peripheral neuropathy ≥ grade 2
- No immunodeficiency
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent growth factors (sargramostim \[GM-CSF\] or filgrastim \[G-CSF\])
- Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Endocrine therapy
- Not specified
- Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
- Surgery
- Not specified
- Other
- No other concurrent investigational agents unless approved by the principal investigator and medical monitor
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00084734
Start Date
May 1 2002
End Date
December 1 2009
Last Update
August 4 2023
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001