Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT00520676
• Recruitment Status: Completed
• First Posted: August 24, 2007
• Results First Posted: July 18, 2011
• Last Update Posted: August 10, 2011
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Study Description

Brief Summary:

The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: pemetrexed; Drug: docetaxel; Drug: carboplatin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
• Study Start Date: October 2007
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: pemetrexed plus carboplatin; Drug: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram*minute/milliLiter (mg*min/mL), IV, q 21 days x 6 cycles maximum	Drug: pemetrexed; 500 mg/m^2, IV, q 21 days x 6 cycles maximum; Other Names: LY231514; Alimta; Drug: carboplatin; AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
Active Comparator: docetaxel plus carboplatin; Drug: docetaxel 75 mg/m^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum	Drug: docetaxel; 75 mg/m^2, IV, q 21 days x 6 cycles maximum; Drug: carboplatin; AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum

Outcome Measures

Primary Outcome Measures :

1. Survival Without Grade 3 or 4 Toxicity [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]

   Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.

   Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.

Secondary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
   OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.
2. Progression-free Survival (PFS) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
   Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.
3. Percentage of Participants With Tumor Response (Response Rate) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
   Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.
4. Survival Without Clinically Important Grade 3 or 4 Toxicity [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
   Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.
5. Survival Without Grade 4 Toxicity [ Time Frame: Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months). ]
   Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.
6. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
   Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Other Outcome Measures:

1. Duration of Response [ Time Frame: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). ]
   The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
• Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
• Estimated life expectancy of at least 8 weeks

Exclusion Criteria:

• Known or suspected brain metastases
• Concurrent administration of any other tumor therapy
• Serious concomitant disorders
• Pregnancy or breast feeding
• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Contacts and Locations

Locations

Australia, Victoria

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.

Ballarat, Victoria, Australia, 3350

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Frankston, Victoria, Australia, 3199

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Wendouree, Victoria, Australia, 3355

Australia, Western Australia

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Bunbury, Western Australia, Australia, 6230

Brazil

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Barretos, Brazil, 14784700

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Goiania, Brazil, 74075040

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Santo André, Brazil, 09060-020

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São Paulo, Brazil, 01224 010

China

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Beijing, China, 100036

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Nanjing, China, 210002

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Shanghai, China, 200032

Korea, Republic of

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Seoul, Korea, Republic of, 120-752

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Suwon-City, Korea, Republic of, 442-723

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Ulsan, Korea, Republic of, 682-714

Mexico

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Ciudad Obregon, Mexico, 85100

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Durango, Mexico, 34208

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Mexicali, Mexico, 21000

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Mexico City, Mexico, 11640

Taiwan

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Taichung, Taiwan, 404

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Tao-Yuan, Taiwan, 333

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

More Information

Additional Information:

Lilly Clinical Trial Registry 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pereira JR, Cheng R, Orlando M, Kim JH, Barraclough H. Elderly subset analysis of randomized phase III study comparing pemetrexed plus carboplatin with docetaxel plus carboplatin as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. Drugs R D. 2013 Dec;13(4):289-96. doi: 10.1007/s40268-013-0032-6.

• Responsible Party: Chief Medical Officer, Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT00520676
• Other Study ID Numbers: 11626; H3E-CR-S380 ( Other Identifier: Eli Lilly and Company )
• First Posted: August 24, 2007
• Results First Posted: July 18, 2011
• Last Update Posted: August 10, 2011
• Last Verified: August 2011

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; Carboplatin; Docetaxel; Pemetrexed; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors