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Phase I/II Trial of Gemcitabine/Pemetrexed Combination in Patients With Advanced Cutaneous T-Cell Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase I/II Trial of Gemcitabine/Pemetrexed Combination in Patients With Advanced Cutaneous T-Cell Lymphoma


OBJECTIVES:

Primary

- 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)

Secondary

- 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
response.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed* mycosis fungoides or Sézary syndrome

- Stage IB-IVB disease NOTE: *Pathology report must read diagnostic or consistent
with mycosis fungoides/Sézary syndrome

- Failed ≥ 1 prior systemic treatment

- Measurable disease

- At least 1 indicator lesion must be designated prior to study entry

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 6 months

- Creatinine ≤ 2.0 mg/dL

- Creatinine clearance ≥ 45 mL/min

- Bilirubin ≤ 2.2 mg/dL

- AST and ALT ≤ 2 times upper limit of normal

- WBC ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- No acute infection requiring systemic treatment

- No history of severe hypersensitivity reaction to the study drugs or to any other
ingredient used in their formulation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 4 weeks since prior topical therapy, systemic chemotherapy, or biological
therapy

- No acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 2
days before and for 2 days after pemetrexed disodium infusion (5 days before and for
2 days after pemetrexed disodium infusion for patients taking NSAIDs with a long
half-life [e.g., naproxen, refocoxib, or celecoxib])

- No concurrent topical agents except emollients

- No other concurrent topical or systemic anticancer therapies

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Phase I

Outcome Description:

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.

Outcome Time Frame:

Every 2 weeks of 28 day cycle

Safety Issue:

Yes

Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NU 05H8

NCT ID:

NCT00369629

Start Date:

June 2006

Completion Date:

September 2014

Related Keywords:

  • Lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • stage I 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
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611