Overview

Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Status:
Completed
Trial end date:
2001-08-01
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 trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Irinotecan
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically proven locally advanced (unresectable or recurrent)
or metastatic solid tumor No bone metastases, abnormal radionuclide bone scan or pleural
effusions as the sole indicators of disease No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if
liver metastases present) No Gilbert's Disease Renal: Creatinine no greater than 1.5 mg/dL
Serum calcium less than 12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable
angina No active angina No New York Heart Association class III or IV heart disease No
uncontrolled asymptomatic congestive cardiac failure At least 6 months since any myocardial
infarction Pulmonary: No interstitial pulmonary fibrosis Other: No history of seizure
disorder and receiving phenytoin, phenobarbital, or other antiepileptic medication No
active or uncontrolled infection No uncontrolled diabetes mellitus Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior
chemotherapy regimen allowed Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy and recovered No prior mantle, hemibody, pelvic, or lumbar
spine irradiation Surgery: Not specified