A Phase II NCCTG study of irinotecan and docetaxel in previously treated patients with non-small cell lung cancer

Julian Molina, Daniel Nikcevich, Shauna Hillman, Susan Geyer, Timothy Drevyanko, James Jett, Joseph Verdirame, Henry Tazelaar, Kendrith Rowland, Edward Wos, Leila Kutteh, Suresh Nair, Tom Fitch, Patrick Flynn, Philip Stella, Alex Adjei

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Purpose: This Phase II study was undertaken to define the efficacy and toxicity of the combination of docetaxel and irinotecan for the second-line treatment of non-small cell lung cancer (NSCLC). Patients and Methods: Forty-six patients with measurable NSCLC who had relapsed after an initial response to chemotherapy or who had failed to respond to initial chemotherapy, received 130 mg/m 2 of irinotecan IV over 90 minutes and 50 mg/m 2 docetaxel IV over 60 minutes on Day 1 q3 weeks for 6 cycles. Dexamethasone and diphenhydramine pretreatment were given. Response to treatment was evaluated by response evaluation criteria in solid tumors RECIST criteria, and toxicity was graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0. Results: The most common severe (NCI CTC Grade 3+) adverse events were neutropenia (67 percent), diarrhea (28 percent), fatigue (20 percent), nausea (17 percent), infection (15 percent), vomiting (13 percent), leucopenia (13 percent), abdominal pain (11 percent), and dyspnea (11 percent). Grade 5 toxic events were seen in 2 patients. One of these 2 cases was a possibly-treatment related event (intestinal fistula). The median number of treatment cycles received was 3. Twelve patients (26 percent) received all 6 cycles of treatment. Five patients (11 percent) had a confirmed response (complete response (CR), partial response (PR), or regression). Median follow-up for the five surviving patients is 26.5 months (range: 25.1-28.4). Forty-two patients have reported progressive disease and 41 patients have died. Median time-to-progression (TTP) and survival are 2.6 months and 7.5 months, respectively. Conclusion: This second-line treatment regimen of irinotecan and docetaxel in NSCLC patients has shown activity, but can not be recommended over single-agent regimens because of significant toxicity.

Original languageEnglish (US)
Pages (from-to)382-389
Number of pages8
JournalCancer Investigation
Issue number4
StatePublished - Jun 2006


  • Docetaxel
  • Irinotecan
  • Second-line therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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