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
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
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
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