Overview

Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Camptothecin
Docetaxel
Irinotecan
Criteria
DISEASE CHARACTERISTICS: Histologically proven solid malignancy for which no effective
therapy is currently available CNS metastases allowed if CNS disease is stable for at least
4 weeks following completion of surgery and/or radiotherapy

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: At least 3 months Life
expectancy: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin less than 1.2 mg/dL SGOT and/or SGPT no
greater than 1.5 times upper limit of normal (ULN) (no greater than 2.5 times ULN allowed
if alkaline phosphatase no greater than ULN) Alkaline phosphatase no greater than 2.5 times
ULN (no greater than 4 times ULN allowed if SGOT and/or SGPT no greater than ULN) Renal:
Creatinine clearance at least 55 mL/min Other: HIV negative No active infection Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No concurrent medical condition that would preclude compliance with study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy regimens containing topotecan, irinotecan, or docetaxel At least 4 weeks since
other prior chemotherapy (6 weeks since prior nitrosoureas, melphalan, or mitomycin)
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks
since prior wide field radiotherapy No prior radiotherapy to greater than 20% of bone
marrow Surgery: See Disease Characteristics Recovered from any prior surgery Other: No
other concurrent investigational agents