A phase II study of rebeccamycin analog (NSC-655649) in metastatic renal cell cancer

摘要: Objective: Rebeccamycin analog (NSC-655649) is an antibiotic with antitumor properties demonstrated in preclinical and phase I studies. We conducted a II trial to evaluate the efficacy toxicity of this agent patients advanced renal cell cancer (RCC). Methods: Eligible had histologically or cytologically confirmed diagnosis RCC that was either locally unresectable, recurrent, metastatic. Patients have measurable disease, no prior chemotherapy, life expectancy greater than 12 weeks, Eastern Cooperative Oncology Group (ECOG) performance status 0–2, adequate-organ function, be ≥18 years old. were treated NSC-655649 at dose 165 mg/m2 daily i.v. over 30–60 min for 5 days. Treatment repeated every 21 Response assessed two courses. Results: Twenty-four enrolled. There sixteen males eight females median age 60.5 (range 42–76). Nineteen Caucasians, seventeen nephrectomy, thirteen immunotherapy. The major myelosuppression grade 3 4 neutropenia 38% anemia 33% patients. partial responses (2/24, 8%) 11 (46%) achieved stable disease (SD). 6-month progression-free rate SD 30%. Of progressive registration, one PR SD. overall survival time all 24 10.0 months (90% CI=5.2, 17.4 months). 12-month 39%, 90% CI=(0.21, 0.58). Nine are still alive times ranging from 3.8 24.2 months, follow-up 11.9 months. Conclusion: well tolerated has modest activity RCC.