Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00301808
First received: March 9, 2006
Last updated: August 12, 2012
Last verified: August 2012
  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
Radiation: Radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Survival [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Date of registration to the date of death ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: November 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Drug: Cisplatin
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Other Names:
  • Platin
  • Cisplatinum
Drug: Docetaxel
Docetaxel 75 mg/m2 on day 1 of each cycle
Other Name: Taxotere®
Drug: Pemetrexed disodium
Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Other Name: Alimta
Radiation: Radiation therapy
Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.

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
Detroit, Michigan, United States, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided by Barbara Ann Karmanos Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shirish Gadgeel, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00301808     History of Changes
Other Study ID Numbers: CDR0000461591, P30CA022453, WSU-D-2934, WSU-0507002542
Study First Received: March 9, 2006
Last Updated: August 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 16, 2014