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Completed

NCT Number: NCT00191308

Molecular Profiling in Lung Cancer Patients

The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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., Bystra, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pathologic documentation of non-small cell lung cancer (NSCLC)
  • tumor must be accessible by bronchoscopy for tumor tissue sample collection
  • patients must have lung cancer with clinical stage IB, II, IIIA
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)

Exclusion criteria

  • bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors)
  • pregnant or breast feeding patients
  • patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  • patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
  • unwillingness to take folic acid or vitamin B12 supplementation

Treatment and study plan

Pemetrexed

Drug

500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs

Other names: LY231514, Alimta

Cisplatin

Drug

75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs

Radical Non-Small Cell Lung Cancer (NSCLC) surgery

Procedure

All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.

Primary outcomes

  1. High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood

    Time frame: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)

    Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.

Secondary outcomes

  1. Percentage of Participants With Objective Tumor Response (Response Rate)

    Time frame: Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)

    Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.

  2. Duration of Response

    Time frame: Time of response to disease progression (up to 44.4 months)

    The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. 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.

  3. Disease Free Survival (DFS)

    Time frame: Treatment start to disease progression or death from any cause (up to 45.5 months)

    DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.

  4. Overall Survival (OS)

    Time frame: Treatment start to death from any cause (up to 47.6 months)

    OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy

Important dates

Study start
2005
Primary completion
2008
Study completion
2010
First posted
Sep 19, 2005
Registry last updated
Oct 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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