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Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00407550
  Purpose

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label
Official Title: A Randomized Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer

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

Primary Outcome Measures:
  • Response rate (complete and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall and progression-free survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2006
Detailed Description:

OBJECTIVES:

Primary

  • Compare response rates in patients with stage IIIB or IV non-small cell lung cancer treated with two different treatment schedules of pemetrexed disodium and gemcitabine hydrochloride.

Secondary

  • Compare time-to-event efficacy variables in patients treated with these regimens.
  • Compare progression-free and overall survival of patients treated with these regimens.
  • Compare time to progressive disease and time to treatment failure in patients treated with these regimens.
  • Compare duration of response in patients treated with these regimens.
  • Determine the overall toxicity of these regimens in these patients.

OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified according to disease stage (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 80 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 or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIB (with controlled pleural effusion) OR stage IV disease
  • At least 1 measurable lesion whose longest diameter is ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No medically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures
  • No documented brain metastases unless all of the following criteria are met:

    • Successful local therapy has been completed
    • At least 2 weeks since prior corticosteroids
    • Brain imaging required for symptomatic patients only (to rule out brain metastases)
  • Concurrent enrollment in clinical trial MCCRC-RC0527 required

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 12 weeks
  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • AST and ALT ≤ 3 times ULN (5 times ULN for liver involvement)
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to take folic acid, cyanocobalamin (vitamin B12) supplementation, or dexamethasone and corticosteroids
  • Able to interrupt intake of aspirin and nonsteroidal anti-inflammatory agents for a total of 5 days
  • No severe and/or uncontrolled medical conditions, including any of the following:

    • Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
    • Angina pectoris
    • Congestive heart failure within the past 3 months, unless ejection fraction > 40%
    • Myocardial infarction within the past 6 months
    • Cardiac arrhythmia
    • Diabetes
    • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
    • New York Heart Association class III or IV heart disease
    • Clinically significant infection
  • No other serious medical condition or illness that would preclude study participation
  • No peripheral neuropathy ≥ grade 2
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer
  • No significant weight loss (≥ 10%) within the past 6 weeks
  • No investigator site personnel directly affiliated with the study, or immediate family (i.e., spouse, parent, child, or sibling, whether biological or legally adopted)
  • No employees of Eli Lilly (i.e., employees, temporary contract workers, or designees responsible for conducting the study)

    • Immediate family of Eli Lilly employees may participate in Eli Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly facility

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 2 weeks since prior corticosteroids
  • At least 4 weeks since prior radiation therapy involving > 25% of the bone marrow and recovered
  • At least 30 days since prior investigational therapy
  • No prior radiation therapy to the whole pelvis
  • No prior systemic chemotherapy for advanced non-small cell lung cancer
  • No prior pemetrexed disodium and/or gemcitabine hydrochloride
  • No prior or concurrent sorafenib tosylate and/or temsirolimus
  • No concurrent Hypericum perforatum (St. John's wort)
  • No other concurrent antitumor therapy
  • No concurrent agents that stimulate thrombopoiesis
  • Concurrent palliative radiation therapy allowed
  • Concurrent corticosteroids allowed for adrenal insufficiency or severe nausea and vomiting
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407550

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Julian Molina, MD, PhD Mayo Clinic
  More Information

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

Study ID Numbers: CDR0000516012, MCCRC-RC0524
Study First Received: December 4, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00407550  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009