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

NCT00529100 | Completed Phase 1 Results

• 2 other identifiers: 10259H3E-CA-JMHU
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy

  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.

  Baseline to measured progressive disease (PD; up to 1 year)

• Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year

  OS was defined as the time from date of enrollment to death due to any cause.

  Baseline to date of death from any cause (up to 1 year)

Secondary Outcomes (7)

• Phase 1: Number of Participants With Adverse Events (AE; Toxicity)

  Baseline to measured PD (up to 1 year)

• Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years

  Baseline and 2 years and 3 years

• Phase 2: Time to Progressive Disease (PD)

  Baseline to measured PD (up to 3 years)

• Phase 2: Percentage of Participants With Progression Free Survival (PFS)

  Baseline and 1 year and 2 years and 3 years

• Progression Free Survival (PFS)

  Baseline to measured PD (up to 36 months)

Study Arms (2)

Pemetrexed/Cisplatin/Radiation Phase 1

EXPERIMENTAL

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; Drug: Cisplatin Phase 1; Procedure: Radiation Therapy

Pemetrexed/Cisplatin/Radiation Phase 2

EXPERIMENTAL

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; Drug: Pemetrexed Phase 2; Drug: Cisplatin Phase 2

Interventions

Pemetrexed Phase 1 DRUG

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

Also known as: LY231514, Alimta

Pemetrexed/Cisplatin/Radiation Phase 1

Cisplatin Phase 1 DRUG

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.

Pemetrexed/Cisplatin/Radiation Phase 1

Radiation Therapy PROCEDURE

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

Pemetrexed/Cisplatin/Radiation Phase 1; Pemetrexed/Cisplatin/Radiation Phase 2

Pemetrexed Phase 2 DRUG

Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m\^2 IV on Days 1 and 22.

Also known as: LY231514, Alimta

Pemetrexed/Cisplatin/Radiation Phase 2

Cisplatin Phase 2 DRUG

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.

Pemetrexed/Cisplatin/Radiation Phase 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

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, T6G 1Z2, Canada

Location

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, L8V 5C2, Canada

Location

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, K1H 8L6, Canada

Location

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, M5G 2M9, Canada

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: December 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2012
• Last Updated: July 9, 2013
• Results First Posted: September 28, 2011

Record last verified: 2013-07

Locations

CA (4)