Investigational New Drugs

, Volume 24, Issue 5, pp 447–454 | Cite as

Phase II study of mitomycin-C, adriamycin, cisplatin (MAP) and Bleomycin-CCNU in patients with advanced cancer of the anal canal: An eastern cooperative oncology group study E7282

  • Minaxi Jhawer
  • Sridhar Mani
  • Myrto Lefkopoulou
  • Richard G. Hahn
  • Jules Harris
  • Paul J. Catalano
  • Daniel Haller
Phase II Studies


Metastatic anal cancer is a rare disease in the Western hemisphere and current treatment modalities are not effective. In this study, patients with advanced epithelial cancer of the anal canal received MAP followed by Bleomycin and CCNU upon progression of disease. Twelve out of twenty eligible patients had a partial response 60%, (95% CI {36% −81%}). No complete responses were observed. The median survival was 15 months (95% CI {6–20} months). The median time to progression or death was 8 months (95% CI {4–9 months}). Toxicities were moderate and tolerable with routine supportive care; there were 2 cases of grade 3 vomiting, 2 cases of respiratory distress (one grade 1 and one grade 3), one case each of grade 3 leg cramps and cardiac arrhythmia. Of particular note were 7 cases of grade 3 hematologic toxicity. Two patients had grade 4 leukopenia and thrombocytopenia, respectively, that resolved without sequelae. The combination therapy of MAP followed by Bleomycin and CCNU for patients with advanced anal cancer, not amenable to radiotherapy or surgery, results in a moderate objective response but with moderate toxicities. This regimen and sequence is worthy of further study especially in combination with colony stimulating factors, however, its tolerability may be most applicable for patients who have had minimal prior therapy.


Anal cancer Mitomycin-C Adriamycin Cisplatin Bleomycin CCNU Phase II 


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Copyright information

© Springer Science + Business Media, LLC 2006

Authors and Affiliations

  • Minaxi Jhawer
    • 1
  • Sridhar Mani
    • 1
  • Myrto Lefkopoulou
    • 2
  • Richard G. Hahn
    • 3
  • Jules Harris
    • 4
  • Paul J. Catalano
    • 2
  • Daniel Haller
    • 5
  1. 1.Department of OncologyMontefiore Medical Center, Weiler HospitalBronx10461
  2. 2.Dana-Farber Cancer InstituteBoston
  3. 3.Mayo ClinicRochester
  4. 4.Rush PresbyterianSt. Luke’s Medical CenterChicago
  5. 5.University of Pennsylvania Cancer CenterPhiladelphia

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