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
- Registration Number
- NCT00660231
- Lead Sponsor
- University College, London
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GemBex gemcitabine hydrochloride 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. GemBex bexarotene 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.
- Primary Outcome Measures
Name Time Method Rate of objective response at 24 weeks
- Secondary Outcome Measures
Name Time Method Duration and durability of objective disease response up to 5 years after treatment start Time from first date of treatment to the first date of diagnosis of progressive disease
Assessment of quality of life up to 5 years after treatment start
Trial Locations
- Locations (7)
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
St. Thomas' Hospital
🇬🇧London, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom