Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT00259285
• Recruitment Status: Terminated
• First Posted: November 29, 2005
• Results First Posted: June 2, 2009
• Last Update Posted: June 2, 2009
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Tracking Information

• First Submitted Date: November 28, 2005
• First Posted Date: November 29, 2005
• Results First Submitted Date: December 19, 2008
• Results First Posted Date: June 2, 2009
• Last Update Posted Date: June 2, 2009
• Study Start Date: November 2005
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2009)

Treatment Response [ Time Frame: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle ]

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

• Original Primary Outcome Measures (submitted: November 28, 2005): Lesion measurement in baseline and after the third cycle of treatment.

Current Secondary Outcome Measures (submitted: April 7, 2009)

• Pathologic Remissions After Surgery [ Time Frame: surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) ]
  The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.
• Relapse-free Survival [ Time Frame: Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter ]
  Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.

Original Secondary Outcome Measures (submitted: November 28, 2005)

• Surgical resectability rate,
• Pathologic remissions rate after surgery
• toxicity (adverse events)
• Relapse-free survival
• Pharmacogenomic determinations and their correlation with the response rate obtained and relapse-free survival
• Objective response rate using PET and its correlation with the objective response rate obtained using CT and with the pathological response.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer
• Official Title: Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer
• Brief Summary: To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small-Cell Lung Cancer

Intervention

• Drug: pemetrexed
  500 mg/m2, intravenous (IV), every 21 days x 3 cycles
  Other Names:

  • LY231514
  • Alimta
• Drug: cisplatin
  75 mg/m2, intravenous (IV), every 21 days x 3 cycles

Study Arms

Experimental: A

Interventions:

• Drug: pemetrexed
• Drug: cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 7, 2009): 10
• Original Enrollment (submitted: November 28, 2005): 44
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of non-small-cell carcinoma of the lung
• Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon
• Tumour with possibility of curative surgery
• At least one uni-dimensionally measurable lesion
• Adequate pulmonary function to perform the planned surgical resection

Exclusion Criteria:

• Active infection (at the investigator's discretion)
• Pregnancy or breast-feeding
• Serious concomitant illness at the investigator's discretion
• Previous diagnosis of malignant disease
• They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT00259285
• Other Study ID Numbers: 9901; H3E-XM-S092
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chief Medical Officer, Eli Lilly
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST); Eli Lilly and Company

• PRS Account: Eli Lilly and Company
• Verification Date: April 2009