Search / Trial NCT00001428

A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination With Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Chemotherapy Cytokine Efficacy Palliation Solid Tumor

Description

This protocol will evaluate the activity of 5-Fluorouracil (FUra) given as a 1 hour infusion in combination with leucovorin (LV) and interferon IFN alpha-2a in patients with advanced, measurable colorectal cancer. IFN alpha-2a will be given at 5 million U/m(2) SC days 1-6; LV, 200 mg/m(2), will be given as a short infusion over 30 minutes days 2-6, followed immediately by a 1 hour IV infusion of FUra days 2-6. The starting dose of FUra will be 425 mg/m(2)/d(1). Cycles will be repeated at three week intervals provided that the granulocyte count and platelet count have recovered to &gte; 1200...

Gender

All

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Unresectable primary colorectal adenocarcinoma that is metastatic or recurrent.
  • Objectively measurable disease required.
  • No cerebral metastases.
  • PRIOR/CONCURRENT THERAPY:
  • Biologic Therapy:
  • No history of intolerance to interferon alfa (IFN-A).
  • At least 4 weeks since immunotherapy and recovered.
  • Chemotherapy: No prior chemotherapy for metastatic or recurrent disease. At least 6 months since adjuvant chemotherapy with fluorouracil (5-FU) in combination with levamisole, leucovorin (CF), or IFN-A Interval waived for 5-FU (with or without CF) as a radiosensitizer only . No dose-limiting toxicity with prior 5-FU.
  • Endocrine Therapy: Not specified
  • Radiotherapy: At least 2 weeks since palliative radiotherapy and recovered. Prior definitive pelvic or whole or upper abdominal radiotherapy allowed in the absence of current radiation enteritis.
  • Surgery: Prior surgery allowed with adequate healing/recovery
  • Patient Characteristics:
  • Age: 18 and over.
  • Performance status: ECOG 0 or 1.
  • Hematopoietic:
  • AGC at least 2,000.
  • Platelets at least 100,000.
  • Hepatic: Bilirubin no greater than 2.0 mg/dL
  • Renal: Creatinine no greater than 2.0 mg/dL
  • Cardiovascular:
  • No MI within the past year.
  • No active ischemic heart disease.
  • No NYHA class III/IV status.
  • No symptomatic arrhythmia.
  • OTHER:
  • No requirement for pharmacologic steroid doses for inflammatory or autoimmune disorders. Physiologic replacement doses of steroids allowed.
  • No concurrent cimetidine or oxypurinol.
  • No HIV antibody.
  • No history of seizure disorder.
  • No active infection or other serious concurrent medical illness that would preclude treatment.
  • No second malignancy within 3 years except curatively treated: In situ carcinoma of cervix, Basal cell carcinoma of the skin.
  • No pregnant or nursing women.
  • Effective contraception required of fertile patients.

Attachments

readout_NCT00001428_2023-12-10.pdf

4.5 MB

NCT00001428_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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