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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors  Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel when combined with cisplatin and irinotecan in patients with locally advanced or metastatic solid tumors. II. Determine the dose limiting toxicity of paclitaxel when combined with cisplatin and irinotecan in this patient population. III. Establish the recommended phase II dose for this regimen in this patient population. IV. Assess the antitumor activity of this regimen in selected solid tumor malignancies. PROTOCOL OUTLINE: This is a dose escalation study of paclitaxel. All patients receive paclitaxel IV over 1 hour, then cisplatin IV over 30 minutes, followed by irinotecan IV over 30 minutes weekly for 4 weeks on days 1, 8, 15, and 22. Treatment is repeated every six weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel. If 2 or more patients experience dose limiting toxicity (DLT) at a particular dose level, escalation ceases and the maximum tolerated dose (MTD) is defined as the previous dose level. Patients are followed until death. PROJECTED ACCRUAL: Approximately 12-27 patients will be accrued for this study within 6-9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidIlson, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000066860; MSKCC-98100,NCI-G99-1495
Study Start Date: October 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003742
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
2. Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
3. Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
4. 3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
5. Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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