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

NCT00301808 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000461591P30CA022453WSU-D-2934WSU-0507002542
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Probability of Overall Survival at One Year

  Overall Survival at one year using Kaplan-Meier product-limit analysis

  at 1 year

Secondary Outcomes (3)

• Progression-free Survival

  Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.

• Overall Survival

  Date of registration to the date of death

• Safety Outcomes

  72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year

Study Arms (1)

Cisplatin, Docetaxel & Radiation Therapy

EXPERIMENTAL

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; Drug: Docetaxel; Drug: Pemetrexed disodium; Radiation: Radiation therapy

Interventions

Cisplatin DRUG

Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43

Also known as: Platin, Cisplatinum

Cisplatin, Docetaxel & Radiation Therapy

Docetaxel DRUG

Docetaxel 75 mg/m2 on day 1 of each cycle

Also known as: Taxotere®

Cisplatin, Docetaxel & Radiation Therapy

Pemetrexed disodium DRUG

Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43

Also known as: Alimta

Cisplatin, Docetaxel & Radiation Therapy

Radiation therapy RADIATION

Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.

Cisplatin, Docetaxel & Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• Gadgeel SM, Ruckdeschel JC, Patel BB, Wozniak A, Konski A, Valdivieso M, Hackstock D, Chen W, Belzer K, Burger AM, Marquette L, Turrisi A. Phase II study of pemetrexed and cisplatin, with chest radiotherapy followed by docetaxel in patients with stage III non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):927-33. doi: 10.1097/JTO.0b013e3182156109.

  PMID: 21415776 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Docetaxel; Pemetrexed; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Limitations and Caveats

Study being a single institution, single arm study.

Results Point of Contact

• Title: Shrish Gadgeel, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

sgadgee1@hfhs.org

(313) 556-8820

Study Officials

• Shirish M. Gadgeel, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: November 1, 2005
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 6, 2023
• Results First Posted: May 13, 2014

Record last verified: 2014-07

Locations

US (2)