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Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00529100
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : September 28, 2011
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Pemetrexed Phase 1 Drug: Cisplatin Phase 1 Procedure: Radiation Therapy Drug: Pemetrexed Phase 2 Drug: Cisplatin Phase 2 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
Study Start Date : December 2005
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pemetrexed/Cisplatin/Radiation Phase 1
Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
Drug: Pemetrexed Phase 1
300 mg/m^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m^2 IV; then 500 mg/m^2 IV, repeated every 21 days (q 21 days) x 2 cycles
Other Names:
  • LY231514
  • Alimta

Drug: Cisplatin Phase 1

Cohorts 1-3: 25 mg/m^2 IV, Days 1-3 and 22-24 then 75 mg/m^2 IV, q21 days x 2 cycles

Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.


Procedure: Radiation Therapy
Phases 1 and 2: 61-65 Gy in 33-35 fractions

Experimental: Pemetrexed/Cisplatin/Radiation Phase 2
Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
Procedure: Radiation Therapy
Phases 1 and 2: 61-65 Gy in 33-35 fractions

Drug: Pemetrexed Phase 2
Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22.
Other Names:
  • LY231514
  • Alimta

Drug: Cisplatin Phase 2
Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.




Primary Outcome Measures :
  1. Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy [ Time Frame: Baseline to measured progressive disease (PD; up to 1 year) ]
    Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.

  2. Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year [ Time Frame: Baseline to date of death from any cause (up to 1 year) ]
    OS was defined as the time from date of enrollment to death due to any cause.


Secondary Outcome Measures :
  1. Phase 1: Number of Participants With Adverse Events (AE; Toxicity) [ Time Frame: Baseline to measured PD (up to 1 year) ]
    A listing of AEs is located in the Reported Adverse Event module.

  2. Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years [ Time Frame: Baseline and 2 years and 3 years ]
    OS was defined as the time from date of enrollment to death due to any cause.

  3. Phase 2: Time to Progressive Disease (PD) [ Time Frame: Baseline to measured PD (up to 3 years) ]
    Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.

  4. Phase 2: Percentage of Participants With Progression Free Survival (PFS) [ Time Frame: Baseline and 1 year and 2 years and 3 years ]
    The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.

  5. Progression Free Survival (PFS) [ Time Frame: Baseline to measured PD (up to 36 months) ]
    PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).

  6. Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate) [ Time Frame: Baseline to measured PD (up to 3 years) ]
    Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR.

  7. Phase 2: Site of Progressive Disease (PD) [ Time Frame: Baseline to measured PD (up to 3 years) ]
    Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Some of the requirements to be in this study are:

  • Patient must be at least 18 years old.
  • Patient must have been diagnosed with non-small cell lung cancer.
  • Patient must be able to visit the doctor's office once a week.
  • Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.

Exclusion Criteria:

Patients cannot participate in this study for any of the following reasons:

  • Patient has previously had chemotherapy.
  • Patient has previously had thoracic radiation therapy.
  • Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
  • Female patient is pregnant or breast-feeding.
  • Patient is unsuitable to participate in the study in the opinion of the investigator.
  • Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529100


Locations
Canada, Alberta
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamilton, Ontario, Canada, L8V 5C2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottawa, Ontario, Canada, K1H 8L6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00529100     History of Changes
Obsolete Identifiers: NCT00470730
Other Study ID Numbers: 10259
H3E-CA-JMHU ( Other Identifier: Eli Lilly and Company )
First Posted: September 14, 2007    Key Record Dates
Results First Posted: September 28, 2011
Last Update Posted: July 9, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors