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Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00301808
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: docetaxel
Drug: pemetrexed disodium
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Docetaxel Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)

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

Primary Outcome Measures:
  • 1-year survival at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of overall response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity from baseline to 30 days after completion of study treatment [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: July 2005
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel.

Secondary

  • Assess the progression-free survival and overall survival.
  • Assess the toxicity of this regimen.

OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.

After completion of study therapy, patients are followed at 1 month and periodically thereafter.

PROJECTED ACCRUAL: A total of 28 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:

  • Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:

    • Stage IIIA disease, meeting all of the following criteria:

      • Mediastinal lymph node involvement

        • Greater than one mediastinal lymph node enlarged on CT scan, confirmed by positron emission tomography (PET) scan
      • Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan
    • Stage IIIB disease, meeting all of the following criteria:

      • N3 lymph node involvement

        • Enlarged N3 lymph nodes on CT scan confirmed by PET scan

          • Lymph node involvement may not extend to cervical lymph nodes other than supraclavicular lymph nodes
      • Right-sided primary tumor with left vocal cord paralysis
      • Evidence of tumor extension into the mediastinum and/or mediastinal structures by mediastinoscopy, bronchoscopy, or CT scan
      • No evidence of malignant pleural effusion unless effusion is only evident on CT scan
      • No more than 1 parenchymal lesions on the same or opposite sides of the lung
  • No brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

  • SWOG performance status 0 or 1
  • Platelet count ≥ 100,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 45 mL/min
  • Bilirubin normal
  • Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving greater than 20 Gy of radiation ≤ 40%
  • FEV_1 ≥ 70% of predicted
  • DLCO ≥ 50 mL/min
  • No other concurrent malignancy

    • Prior malignancy allowed provided it is in clinical control and is not likely to impact clinical outcome in the opinion of the treating physician
  • No peripheral neuropathy ≥ grade 2
  • No serious medical illness, including, but not limited to, any of the following:

    • Uncontrolled congestive heart failure
    • Uncontrolled angina
    • Myocardial infarction
    • Cerebrovascular event within the past 6 months
    • History of chronic active hepatitis
    • History of HIV infection
    • Active bacterial infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or dexamethasone

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for NSCLC
  • No concurrent participation in another therapeutic investigational study
  • Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium administration provided the patient has normal renal function
  • No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days before, during, and for 2 days after pemetrexed disodium administration

    • Patients on long-acting NSAIDs (e.g. naproxen sodium, diflunisal, nabumetone, or celecoxib) must be willing or able to discontinue usage 5 days prior to, during, and for 2 days after pemetrexed disodium administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301808

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: Shirish M Gadgeel     313-576-8753        
Veterans Affairs Medical Center - Detroit Recruiting
Detroit, Michigan, United States, 48201
Contact: Contact Person     313-576-1000        
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
  More Information

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

Responsible Party: Barbara Ann Karmanos Cancer Institute ( Shirish M. Gadgeel )
Study ID Numbers: CDR0000461591, WSU-D-2934, WSU-0507002542
Study First Received: March 9, 2006
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00301808  
Health Authority: Unspecified

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

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

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

ClinicalTrials.gov processed this record on January 15, 2009