Lung Cancer Clinical Trial
Official title:
Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Antwerpen | Edegem |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful treatment delivery | No | ||
Primary | Toxicity (no grade 4) during chemotherapy | Yes | ||
Secondary | Overall toxicity (all grades) | Yes | ||
Secondary | Progression-free survival and overall survival | No | ||
Secondary | Overall clinical response rate (neoadjuvant chemotherapy arm) | No | ||
Secondary | Pathologic complete response (neoadjuvant chemotherapy arm) | No | ||
Secondary | Resectability rate (neoadjuvant chemotherapy arm) | No | ||
Secondary | Surgical morbidity and mortality | No | ||
Secondary | Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm) | No |
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