Gemcitabine and Bexarotene in Treating Patients With Progressive or Refractory Stage IB, Stage II, Stage III, or Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma (GemBex)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying giving gemcitabine together with bexarotene to see how well it works in treating patients with progressive or refractory stage IB, stage II, stage III, or stage IV cutaneous T-cell non-Hodgkin lymphoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma|
- Rate of objective response [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
- Duration and durability of objective disease response [ Time Frame: up to 5 years after treatment start ] [ Designated as safety issue: No ]Time from first date of treatment to the first date of diagnosis of progressive disease
- Assessment of quality of life [ Time Frame: up to 5 years after treatment start ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||September 2016|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Gemcitabine days 1 and 8 of a 3 week cycle (4 cycles total - 12 weeks) Bexarotene daily: in combination with Gemcitabine during first 12 weeks, then Bexarotene maintenance until disease progression.
Bexarotene daily p.o. 150mg/sq m during week 1 and 2, then 300mg/sq m if tolerated.
Other Name: TargretinDrug: gemcitabine hydrochloride
Gemcitabine i.v. 1000mg/sq m day 1 and day 8 of four 21 day cycles.
- 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 therapy.
- 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 (OPDREC).
- 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 RECIST criteria.
- Evaluate the proportion of patients with clearing of Sézary cells from the blood and bone marrow.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660231
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|St. Thomas' Hospital|
|London, England, United Kingdom, SE1 7EH|
|Manchester, England, United Kingdom, M20 4BX|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Cornwall Hospital|
|Truro, England, United Kingdom, TR1 3LJ|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Principal Investigator:||Tim Illidge||Christie Hospital NHS Foundation Trust|