Status:
TERMINATED
Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Eli Lilly and Company
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodiu...
Detailed Description
OBJECTIVES: 1. Determine the safety and tolerability of gemcitabine hydrochloride and pemetrexed disodium in patients with advanced mycosis fungoides or Sézary syndrome. (Phase I) 2. Determine the ma...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00369629
Start Date
August 28 2006
End Date
June 4 2013
Last Update
August 28 2019
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013