Pemetrexed Disodium and Cisplatin Before or After Surgery in Treating Patients With Stage IB or Stage II Non-Small Cell Lung Cancer That Can be Removed by Surgery

NCT00389688 | Terminated Phase 2

• 2 other identifiers: EORTC-080512005-003822-25
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective before or after surgery in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying the side effects of pemetrexed disodium and cisplatin and comparing how well they work when given before or after surgery in treating patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Successful treatment delivery

• Toxicity (no grade 4) during chemotherapy

Secondary Outcomes (7)

• Overall toxicity (all grades)

• Progression-free survival and overall survival

• Overall clinical response rate (neoadjuvant chemotherapy arm)

• Pathologic complete response (neoadjuvant chemotherapy arm)

• Resectability rate (neoadjuvant chemotherapy arm)

Interventions

cisplatin DRUG

pemetrexed disodium DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Pathologically confirmed non-small cell lung cancer (NSCLC) * Stage IB or II disease * Resectable disease * At least 1 measurable lesion * No mediastinal involvement by mediastinoscopy and/or positron emission tomography with fludeoxyglucose F 18 scan * No evidence of metastatic disease PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 10 g/dL * Creatinine clearance ≥ 60 mL/min * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3.0 times ULN * AST and ALT ≤ 3.0 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignant disease, except for the following: * Basocellular carcinoma of the skin * Adequately treated carcinoma in situ of the cervix * Low-grade prostate cancer * Other cancer for which the patient has been disease-free for ≥ 5 years * No congestive heart failure or angina pectoris unless medically controlled * No myocardial infarction within the past 6 months * No uncontrolled hypertension or arrhythmia * No active uncontrolled infection requiring antibiotics * No illness or medical condition that would preclude study participation * No pre-existing motor or sensory neurotoxicity ≥ grade 2 PRIOR CONCURRENT THERAPY: * No prior surgery for NSCLC * No prior or other concurrent chemotherapy for NSCLC * No prior or concurrent radiotherapy for NSCLC * No concurrent immunotherapy * No concurrent targeted agents * No concurrent hormonal cancer therapy * No concurrent routine colony-stimulating factor (e.g., prophylactic filgrastim \[G-CSF\]) * No aspirin or nonsteroidal anti-inflammatory drugs within 5 days before or after chemotherapy * No other concurrent experimental treatments * No other concurrent anticancer treatments

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Pemetrexed; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Paul Germonpre, MD

  University Hospital, Antwerp

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2008
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

BE (1)