A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma
- Confirm the feasibility and efficacy of the combination of gemcitabine hydrochloride
and bexarotene in patients with cutaneous T-cell lymphoma whose disease is no longer
controlled by skin-directed therapy and who have had at least one prior systemic
- Determine the rate of objective disease control as defined by complete response (CR),
clinical complete response (CCR), partial response (PR), and stable disease (SD) for 6
months as determined by the Objective Primary Disease Response Evaluation Criteria
- Evaluate the duration and durability of objective disease response (CR, CCR and PR) as
determined by OPDREC criteria.
- Evaluate time to objective disease response.
- Determine the safety of this combination in terms of adverse events, clinical
laboratory data, physical examinations, rate of neutropenic fever and sepsis, blood
transfusions, and treatment compliance.
- Determine the time to objective disease progression.
- Determine the time to treatment failure.
- Determine change from baseline in Severity-Weighted Assessment Tool (SWAT) value,
Erythroderma SWAT value, Pruritus Visual Analogue Scale, and ECOG performance status.
- Determine proportion of disease control, response, and progression as determined by
- Evaluate the proportion of patients with clearing of Sézary cells from the blood and
- Measure changes in patient assessed Quality of Life using Skindex 29 and EORTC QLQ-30.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV on days 1 and 8 and oral bexarotene daily on
days 1-21. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease
progression or unacceptable toxicity. After 4 courses of study therapy, patients with
responding disease receive oral bexarotene alone daily until disease progression or
treatment no longer tolerated.
Patients complete a quality of life questionnaire at baseline, during study therapy, and
after completion of study treatment.
After completion of study treatment, patients are followed every 2 months for up to 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of objective response
at 24 weeks
Christie Hospital NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Authority