Phase I/II Trial of Gemcitabine/Pemetrexed Combination in Patients With Advanced Cutaneous T-Cell Lymphoma
- Determine the safety and tolerability of gemcitabine hydrochloride and pemetrexed
disodium in patients with advanced mycosis fungoides or Sézary syndrome. (Phase I)
- Determine the maximum tolerated dose of gemcitabine hydrochloride when administered
with pemetrexed disodium in these patients. (Phase I)
- Evaluate tumor response (cutaneous and extracutaneous manifestations) in patients
treated with this regimen. (Phase II)
- Evaluate synergistic toxic effects associated with this treatment regimen in these
patients. (Phase II)
- Assess response duration in patients treated with this regimen. (Phase II)
- Assess time to response in patients treated with this regimen. (Phase II)
- Assess time to progression in patients treated with this regimen. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride followed by a
phase II study.
- Phase I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine
hydrochloride IV on days 1 and 15. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which ≥ 2 of 6
patients experience dose-limiting toxicity. The recommended phase II dose is defined as the
dose one level below the MTD.
- Phase II: Patients receive pemetrexed disodium and gemcitabine hydrochloride at the
recommended phase II dose as in phase I. Treatment continues for ≥ 2 courses in the
absence of unacceptable toxicity or disease progression or for 2 courses past maximum
After completion of study treatment, patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Phase I
To determine safety and tolerability associated with gemcitabine, administered via the dose-rate schedule every 2 weeks, and pemetrexed, administered every 2 weeks of a 28 day cycle, as combination therapy in patients with advanced stage mycosis fungoides/Sézary syndrome based on adverse events such as clinical and laboratory findings.
Every 2 weeks of 28 day cycle
Timothy M. Kuzel, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|