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Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
This study is ongoing, but not recruiting participants.
First Received: May 6, 2003   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00060190
  Purpose

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with gemcitabine works in treating patients with pleural or peritoneal malignant mesothelioma.


Condition Intervention Phase
Malignant Mesothelioma
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Phase II

MedlinePlus related topics: Cancer Mesothelioma
Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

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

Study Start Date: February 2003
Detailed Description:

OBJECTIVES:

  • Determine the objective tumor response rate in chemotherapy-naïve patients with malignant pleural mesothelioma treated with pemetrexed disodium and gemcitabine.
  • Determine the median survival of patients with malignant pleural or peritoneal mesothelioma treated with this regimen.
  • Determine the time to objective tumor response and duration of response in patients treated with this regimen.
  • Determine the time to treatment failure in patients treated with this regimen.
  • Determine the time to progressive disease in patients treated with this regimen.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and pemetrexed disodium IV over 8-15 minutes on day 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months.

PROJECTED ACCRUAL: A total of 18-73 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 malignant pleural or peritoneal mesothelioma of 1 of the following subtypes:

    • Epithelial
    • Sarcomatoid
    • Mixed subtype
  • Disease not amenable to curative surgery
  • Measurable disease

    • At least 1 measurable lesion at least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
    • At least 1 level on lesion scan must have 1 pleural rind measurement at least 15 mm
    • If there is only 1 measurable lesion, the neoplastic nature must be histologically confirmed
    • Clinically detected lesions are only considered measurable if superficial (e.g., skin nodules and palpable lymph nodes)
    • The following are not considered measurable disease:

      • Pleural effusions
      • Positive bone scans
  • No known or suspected brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN*
  • ALT and AST no greater than 3 times ULN*
  • Albumin at least 2.5 g/dL NOTE: *No greater than 5 times ULN in the case of liver involvement by tumor

Renal

  • Creatinine clearance at least 45 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • No concurrent serious systemic disorders (including oncologic emergencies) that would preclude study participation
  • No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (patients with previously treated malignancy are eligible if at less than 30% risk of relapse)
  • Able to tolerate folic acid or cyanocobalamin administration

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior intracavitary immunomodulators, unless given for pleurodesis
  • No filgrastim (G-CSF) within 24 hours of study chemotherapy administration
  • No concurrent immunotherapy
  • No concurrent routine colony-stimulating factor therapy
  • No concurrent stimulators of thrombopoiesis

Chemotherapy

  • No prior systemic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy for cancer

Radiotherapy

  • Prior radiotherapy to the target lesion allowed provided the lesion has clearly progressed
  • At least 4 weeks since prior radiotherapy
  • No concurrent non-palliative radiotherapy

Surgery

  • No concurrent surgery for cancer

Other

  • At least 2 weeks since prior pleurodesis
  • No prior intracavitary cytotoxic drugs, unless given for pleurodesis
  • More than 4 weeks since prior investigational agents
  • No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 days of pemetrexed disodium administration

    • No long-acting NSAIDs (e.g., naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) within 5 days of pemetrexed disodium administration
  • No other concurrent experimental medications (except thymidine)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060190

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000299535, CWRU-LILY-1502, LILLY-H3E-US-JMFZ(b)
Study First Received: May 6, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00060190     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Study placed in the following topic categories:
Folic Acid
Antimetabolites
Pemetrexed
Radiation-Sensitizing Agents
Immunologic Factors
Mesothelioma
Folic Acid Antagonists
Gemcitabine
Immunosuppressive Agents
Antiviral Agents
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Pemetrexed
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Mesothelioma
Gemcitabine
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009