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A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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
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

Inclusion Criteria


- Histologically confirmed cutaneous T-cell lymphoma (CTCL) including its variants
(e.g., mycosis fungoides and Sézary syndrome)

- CTCL stage IB, IIA, IIB, III or IVA disease

- No visceral involvement (i.e., stage IVB disease)

- Lymphadenopathy is allowed

- Patients must have developed progressive disease after receiving or have been
refractory to at least 1 course of prior standard, systemic, skin-directed therapy
(e.g., interferon, chemotherapy, or denileukin diftitox [Ontak®])

- No CD30 + (Ki1+ve) anaplastic large cell lymphoma


- ECOG performance status 0-1

- Life expectancy > 6 months

- Hemoglobin ≥ 9.0 g/dL (transfusions and/or erythropoietin are allowed)

- ANC > 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Total bilirubin ≤ 1.25 times upper limit of normal (ULN)

- AST and ALT ≤ 2 times ULN

- Serum creatinine ≤ 2 times ULN

- No clinically significant active infection

- No uncontrolled diabetes mellitus

- No excessive alcohol consumption

- No biliary tract disease

- No history of pancreatitis

- HIV negative

- Hepatitis B and C negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study

- No other malignancy within the past 5 years except curatively treated basal or
squamous cell skin cancer, cervical epithelial neoplasm CIN1, or carcinoma in situ

- No other significant medical or psychiatric condition that would preclude study


- See Disease Characteristics

- More than 4 weeks since any prior investigational agent

- More than 2 weeks since prior topical steroids or more than 4 weeks since prior
systemic steroids

- Local radiotherapy may be given to isolated symptomatic tumour nodules that require
immediate treatment for up to 2 weeks prior to study drugs

- No prior treatment with bexarotene (Targretin®)

- No concurrent anticancer therapy

- No concurrent investigational agent

- No concurrent drug therapy with other medications that can elevate triglycerides or
cause pancreatic toxicity (e.g., gemfibrozil)

- No concurrent warfarin

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of objective response

Outcome Time Frame:

at 24 weeks

Safety Issue:


Principal Investigator

Tim Illidge

Investigator Role:

Principal Investigator

Investigator Affiliation:

Christie Hospital NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Authority

Study ID:




Start Date:

March 2008

Completion Date:

September 2016

Related Keywords:

  • Lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage IB mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage IB cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous