Combination Chemotherapy in Treating Patients With Advanced 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 advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: docetaxel Drug: fluorouracil Drug: leucovorin calcium |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Docetaxel Plus 5-FU, Cisplatin and Leucovorin in Patients With Advanced Solid Tumors |
| Study Start Date: | January 2000 |
| Study Completion Date: | May 2002 |
| Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel administered in combination with cisplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors. II. Determine the toxicities associated with this combination regimen in this patient population. III. Evaluate the clinical response to this combination regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel and fluorouracil (5-FU). Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 2, and leucovorin calcium IV immediately followed by 5-FU IV on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression. Cohorts of 3-5 patients receive escalating doses of docetaxel and 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of advanced solid tumor No lymphomas Measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AND SGOT no greater than 2.5 times ULN AND Alkaline phosphatase no greater than ULN OR SGOT no greater than ULN AND Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No pre-existing peripheral neuropathy greater than grade 2 Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No more than 2 prior treatments for metastatic disease Biologic therapy: Not specified Chemotherapy: No prior high dose (pre transplant) chemotherapy Prior paclitaxel allowed Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: Not specified
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Study Chair: | Al B. Benson, MD, FACP | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004913 History of Changes |
| Other Study ID Numbers: | NU 98X2, NU-98X2, NCI-G00-1707 |
| Study First Received: | March 7, 2000 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Docetaxel Cisplatin Fluorouracil Leucovorin Levoleucovorin 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 Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on June 17, 2013