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OpenTrials
Completed

NCT Number: NCT00004913

Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

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.

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Key information

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

docetaxel

Drug

Fluorouracil

Drug

leucovorin calcium

Drug

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase I Study of Docetaxel Plus 5-FU, Cisplatin and Leucovorin in Patients With Advanced Solid Tumors

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Mar 16, 2004
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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