Search / Trial NCT00001495

A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors

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

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Camptothecin Cancer Chemotherapy Natural Products Neoplasms

Description

Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the max...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Recurrent or metastatic cancer, including lymphoma.
  • No leukemia.
  • No active CNS disease.
  • Refractory to all effective therapy OR No effective therapy exists.
  • Measurable disease not required.
  • PRIOR/CONCURRENT THERAPY:
  • Biologic Therapy: Greater than 4 weeks and recovered from immunotherapy.
  • Chemotherapy: Greater than 4 weeks and recovered from chemotherapy.
  • Previous therapy with irinotecan is permitted.
  • Endocrine Therapy: Not specified.
  • Radiotherapy: Greater than 4 weeks since radiotherapy.
  • Surgery: Recovered from prior surgery.
  • PATIENT CHARACTERISTICS:
  • Age: 18 and over.
  • Performance status: ECOG 0-2.
  • Hematopoietic: AGC greater than 1,500.
  • Platelets greater than 100,000.
  • Hepatic: Bilirubin no greater than 1.5 mg/dL.
  • AST no greater than 2 times normal.
  • Renal: Creatinine no greater than 1.5 mg/dL.
  • OTHER:
  • HIV negative.
  • No active infection requiring antibiotics.
  • No concurrent medical illness that would interfere with chemotherapy.
  • No pregnant or nursing women.
  • Adequate contraception required of fertile patients.
  • Imaging/exams for tumor measurement within 28 days prior to registration.

About Sponsor

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

Discussion 0