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

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.