Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome - Full Text View

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00369629

Purpose

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 disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine hydrochloride when given together with pemetrexed disodium and to see how well they work in treating patients with advanced mycosis fungoides or Sézary syndrome.

Condition	Intervention	Phase
Lymphoma	Drug: gemcitabine hydrochloride Drug: pemetrexed disodium	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I/II Trial of Gemcitabine/Pemetrexed Combination in Patients With Advanced Cutaneous T-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety and tolerability [ Designated as safety issue: Yes ]
Maximum tolerated dose of gemcitabine hydrochloride [ Designated as safety issue: Yes ]
Tumor response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response duration [ Designated as safety issue: No ]
Time to response [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	June 2006
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369629

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Timothy M. Kuzel, MD	Robert H. Lurie Cancer Center
Investigator:	Christiane Querfeld, MD	Robert H. Lurie Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Timothy M. Kuzel )
Study ID Numbers:	CDR0000491690, NU-05H8, NU-0310-101, LILLY-NU-05H8
Study First Received:	August 24, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00369629 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Folate
Sezary Syndrome
Mycosis Fungoides
Vitamin B9
Lymphoma, Small Cleaved-cell, Diffuse
Mycoses
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Gemcitabine
Lymphoma

Immunoproliferative Disorders
Folic Acid Antagonists
Folinic Acid
Antiviral Agents
Immunosuppressive Agents
Recurrence
Pemetrexed
Folic Acid
Lymphatic Diseases
Radiation-Sensitizing Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Sezary Syndrome
Mycosis Fungoides
Lymphoma, T-Cell
Therapeutic Uses
Gemcitabine
Lymphoma
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Pemetrexed
Lymphatic Diseases
Neoplasms
Radiation-Sensitizing Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on August 12, 2009