Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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Purpose
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 who have locally advanced or metastatic solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: fluorouracil Drug: irinotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Irinotecan, Cisplatin, and Fluorouracil in Patients With Advanced Solid Tumor Malignancies |
| Study Start Date: | October 1999 |
| Primary Completion Date: | July 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the maximum tolerated dose of weekly irinotecan in combination with weekly fluorouracil and cisplatin in patients with locally advanced or metastatic solid tumors. II. Determine the dose limiting toxicity for this combination regimen in this patient population. III. Establish a recommended phase II dose for this combination regimen in these patients. IV. Evaluate the safety and tolerability of this regimen in these patients. V. Observe any responses to this combination chemotherapy in these patients. VI. Measure in pretreatment biopsies levels of expression of thymidylate synthase, topoisomerase I, ERCC-1, thymidine phosphorylase, and dihydropyrimidine dehydrogenase as correlates to response or resistance to this combination chemotherapy in these patients.
OUTLINE: This is a dose escalation study of irinotecan and fluorouracil. Patients receive cisplatin IV over 30 minutes followed by fluorouracil IV over several minutes followed by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression for a minimum of 3 courses. Cohorts of 3-6 patients receive escalating doses of irinotecan and fluorouracil until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed at 30 days and then until death.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor malignancy not amenable to curative surgery or chemoradiation No CNS metastases, carcinomatous meningitis, or interstitial pulmonary fibrosis
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) (5 times ULN if liver metastases) No known Gilbert's disease Renal: Creatinine no greater than 1.5 mg/dL Calcium less than 12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable angina No New York Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active or uncontrolled infection No history of seizure disorder No uncontrolled diabetes mellitus, defined as random blood sugar 250 mg/dL or greater
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior mantle irradiation, hemibody irradiation, or radiation to the pelvis or lumbar spine Surgery: See Disease Characteristics Other: No concurrent phenytoin, phenobarbital, or other antiepileptic medication No concurrent prochlorperazine on day of irinotecan administration No concurrent prophylactic loperamide
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | David H. Ilson, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005791 History of Changes |
| Other Study ID Numbers: | CDR0000067737, MSKCC-99065, NCI-G00-1743 |
| Study First Received: | June 2, 2000 |
| Last Updated: | December 3, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Irinotecan Cisplatin Fluorouracil Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013