NCT00001449

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 1995

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

September 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Neoplasms

Keywords

Anti-Cancer AgentsAntimetabolitePalliationPharmacodynamicsPharmacokinetics

Interventions

gemcitabineDRUG
fluorodeoxyuridineDRUG
leucovorinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Heinemann V, Hertel LW, Grindey GB, Plunkett W. Comparison of the cellular pharmacokinetics and toxicity of 2',2'-difluorodeoxycytidine and 1-beta-D-arabinofuranosylcytosine. Cancer Res. 1988 Jul 15;48(14):4024-31.

    PMID: 3383195BACKGROUND

  • Heinemann V, Xu YZ, Chubb S, Sen A, Hertel LW, Grindey GB, Plunkett W. Cellular elimination of 2',2'-difluorodeoxycytidine 5'-triphosphate: a mechanism of self-potentiation. Cancer Res. 1992 Feb 1;52(3):533-9.

    PMID: 1732039BACKGROUND

  • Heinemann V, Xu YZ, Chubb S, Sen A, Hertel LW, Grindey GB, Plunkett W. Inhibition of ribonucleotide reduction in CCRF-CEM cells by 2',2'-difluorodeoxycytidine. Mol Pharmacol. 1990 Oct;38(4):567-72.

    PMID: 2233693BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

GemcitabineFloxuridineLeucovorin

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyuridineUridineDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

September 1, 1995

Study Completion

April 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-09

Locations

US(1)