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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Docetaxel
Pemetrexed disodium
Radiation therapy
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute
  • Veterans Affairs Medical Center - Detroit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cisplatin, Docetaxel & Radiation Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Probability of Overall Survival at One Year
Overall Survival at one year using Kaplan-Meier product-limit analysis

Secondary Outcome Measures

Progression-free Survival
Progression-free survival using Kaplan-Meier estimates
Overall Survival
Overall survival using Kaplan-Meier estimates
Safety Outcomes
Toxicity: total number of SAEs and other AEs

Full Information

First Posted
March 9, 2006
Last Updated
April 10, 2023
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00301808
Brief Title
Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
Official Title
Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin, Docetaxel & Radiation Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platin, Cisplatinum
Intervention Description
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere®
Intervention Description
Docetaxel 75 mg/m2 on day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Pemetrexed disodium
Other Intervention Name(s)
Alimta
Intervention Description
Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Primary Outcome Measure Information:
Title
Probability of Overall Survival at One Year
Description
Overall Survival at one year using Kaplan-Meier product-limit analysis
Time Frame
at 1 year
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival using Kaplan-Meier estimates
Time Frame
Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.
Title
Overall Survival
Description
Overall survival using Kaplan-Meier estimates
Time Frame
Date of registration to the date of death
Title
Safety Outcomes
Description
Toxicity: total number of SAEs and other AEs
Time Frame
72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirish M. Gadgeel, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21415776
Citation
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.
Results Reference
derived

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

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