Investigational New Drugs

, Volume 24, Issue 1, pp 79–83 | Cite as

Phase I clinical trial of weekly docetaxel and exisulind, a novel inducer of apoptosis

  • Agustin A. Garcia
  • Syma Iqbal
  • David Quinn
  • Susan Edwards
  • Heinz Josef Lenz
  • Jeff Weber


Background: The objective of this phase I study was to determine the maximal tolerated dose (MTD) of the combination of weekly docetaxel and exisulind in patients with advanced solid tumors. Patients and methods: Patients with advanced or refractory solid tumors were treated with intravenous weekly docetaxel with daily oral exisulind. The following dose levels (docetaxel/exisulind) were explored: 30-mg/m2/200 mg po bid, 35/200, 35/250 and 40/250. Docetaxel was administered weekly for 6 weeks followed by 2 weeks off, and exisulind was taken twice daily. Each cycle was 8 weeks. Results: Eighteen patients were enrolled in the study. All of them had received prior systemic therapy. Most patients had either melanoma or carcinomas of the upper gastrointestinal tract. A total of 31 cycles of therapy were administered. DLTs were grade 3 diarrhea, anorexia and fatigue and grade 3 cutaneous toxicity at dose level 4 (40/250). Myelosuppression was mild. Fatigue and gastrointestinal toxicity (anorexia, dyspepsia, nausea, abdominal pain and diarrhea) represented the most common toxicities. However, grade 3 and grade 4 toxicities were uncommon. There were no treatment related deaths. No objective responses were observed and five patients achieved stable disease. Conclusions: The recommended dose for phase II studies is weekly docetaxel 35 mg/m2 for 6 weeks followed by 2 weeks off in combination with oral exisulind 250 mg po bid. This combination is feasible and well-tolerated at these doses.


Chemotherapy docetaxel exisulind metastatic carcinoma phase I trial 


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Copyright information

© Springer Science + Business Media, Inc. 2006

Authors and Affiliations

  • Agustin A. Garcia
    • 1
    • 2
  • Syma Iqbal
    • 1
  • David Quinn
    • 1
  • Susan Edwards
    • 1
  • Heinz Josef Lenz
    • 1
  • Jeff Weber
    • 1
  1. 1.University of Southern California Keck School of Medicine, Kenneth Norris Jr. Comprehensive Cancer CenterLos Angeles
  2. 2.Cedars Sinai Medical Center, Women's Cancer Research Institute, Director Breast Cancer ProgramLos Angeles

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