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Annals of Oncology 11:1463-1470, 2000
© 2000 European Society for Medical Oncology

research-article

Dose escalation of CPT-11 in combination with oxaliplatin using an every two weeks schedule: A phase I study in advanced gastrointestinal cancer patients

F. Goldwasser1,, M. Gross-Goupil1, J.-M. Tigaud1, M. Di Palma1, J. Marceau-Suissa2, E. Wasserman1, A. Yovine1, J.-L. Misset1 and E. Cvitkovic1

1Service de Cancérologie, Hôpital Paul Brousse Villejuif France
2Laboratoires Rhône-Poulenc Rorer Montrouge, France

Correspondence to: F. Goldwasser, MD, PhD Service de Cancérologie, Hôpital Paul Brousse 14 av. Paul Vaillant-Couturier 94804 Villejuif France E-mail: F.Goldwasser{at}wanadoo.fr

BACKGROUND: To determine the dose-limiting toxicity of CPT-11 in combination with oxaliplatin, and the maximal tolerated dose (MTD) and the recommended dose (RD) of CPT-11 using an every two weeks schedule.

PATIENTS AND METHODS: The study was designed to evaluate escalated doses of CPT-11 starting at 100 mg/m2 with a fixed clinically-relevant dose of 85 mg/m2 oxaliplatin given every two weeks.

RESULTS: Twenty-three patients and 186 cycles were evaluable for toxicity (median per patient: 7, range: 1–13). Grade 3 oxaliplatin-induced neurotoxicity was cumulative and limiting in 39% (9 of 23) of patients. The MTD of CPT-11 was 200 mg/m2, with incomplete neutrophil recovery at day 15 as limiting toxicity. At the RD (175 mg/m2 of CPT-11): no grade 4 neutropenia was seen in the two first cycles; 30% of patients experienced grade 3–4 diarrhea. Febrile neutropenia (3.2% of all cycles) was 3-fold more frequent in performance status (PS) 2 than in PS 0–1 patients. Among eleven colorectal cancer (CRC) patients, three complete and four partial responses were documented, including in three 5-fluorouracil (5-FU) refractory patients.

CONCLUSIONS: To combine CPT-11 175 mg/m2 and oxaliplatin 85 mg/m2 every two weeks is feasible in an outpatient setting, and very active in 5-FU resistant CRC patients. A dose of 150 mg/m2 CPT-11 is recommended in PS 2 patients.

colorectal cancer, CPT-11, oxaliplatin, pancreatic cancer, performance status


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