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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001449 |
Purpose
The purpose of this study is to determine the clinical toxicities associated with administering sequential dFdC as a one hour infusion followed by a continuous infusion of FUdR over 24 hours with low dose oral LV weekly for three weeks out of four.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: gemcitabine Drug: fluorodeoxyuridine Drug: leucovorin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Weekly Gemcitabine in Combination With Infusional Fluorodeoxyuridine and Oral Calcium Leucovorin in Adult Cancer Patients |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 1995 |
| Estimated Study Completion Date: | April 2000 |
The MTD and biochemically active dose of FUDR as a 24-hour and gemcitabine as a 2-hour infusion will be determined first (Part A); if the biochemically active FUDR dose is less than the MTD, new patients will be entered to determine the maximum tolerated duration of FUDR infusion (Part B).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnostically proven locally advanced, but unresectable primary or recurrent solid tumors or lymphoma or metastatic solid tumors that have failed standard therapy or no such therapy is available.
Objectively measurable disease not required.
No patients with leukemia or primary or metastatic CNS malignancies.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Greater than 4 weeks since prior immunotherapy and recovered from all toxic effects.
Chemotherapy: Greater than 4 weeks since prior chemotherapy and recovered from all toxic effects with following exceptions: At least 6 weeks since prior mitomycin C or nitrosourea therapy. At least 3 months since prior suramin therapy.
Endocrine Therapy: Not specified
Radiotherapy: At least 2 weeks since prior radiotherapy (4 weeks if at least 21% of marrow irradiated) and recovered from all toxic effects.
Surgery: Recovered from any prior surgery.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: ECOG 0-2
Hematopoietic:
AGC at least 2,000/microL.
Platelet count at least 100,000/microL.
Hepatic: Bilirubin no greater than 2.0 mg/dL.
Renal: Creatinine no greater than 2.0 mg/dL.
OTHER:
No failure of prior gemcitabine therapy.
No concurrent cimetidine (ranitidine and other anti-ulcer agents allowed).
No active infection requiring intravenous antibiotic therapy.
HIV negative.
No other medical contraindication to protocol therapy.
No pregnant or nursing women.
Adequate contraception required of fertile patients.
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00001449 History of Changes |
| Other Study ID Numbers: | 950197, 95-C-0197 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Anti-Cancer Agents Antimetabolite Palliation Pharmacodynamics Pharmacokinetics |
|
Neoplasms Floxuridine Gemcitabine Leucovorin Levoleucovorin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antidotes Protective Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Radiation-Sensitizing Agents |
