Lung Cancer Clinical Trial

CALGB 30704 (NCT00698815) For patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC) using Pemetrexed and/or Sunitinib as Second-Line Therapy

Summary

The purpose of this trial is to compare progression-free survival for patients treated with pemetrexed disodium vs sunitinib malate vs pemetrexed disodium in combination with sunitinib malate as an option after initial treatment is not successful.

Sunitinib is provided at no charge.

Basic Eligibility Criteria:

• Must have evidence of disease progression after first-line therapy
• No cavitary lung lesions
• No pleural effusions (excess fluid in lung space) or ascites (excess fluid in abdomen)
• No symptomatic or untreated CNS (central nervous system) metastases (cancer spread). Patients with CNS metastases are eligible if metastases were definitively treated with surgery or radiotherapy AND patient is asymptomatic and off steroids or on a stable dose of steroids for 2 weeks prior to study entry
• Concurrent enrollment on CALGB-580702 (imaging study) required
• Performance status 0-1
• Not pregnant or nursing
• No ongoing cardiac dysrhythmias (irregular heartbeat)
• No atrial fibrillation (irregular heartbeat in upper chamber)
• No symptomatic congestive heart failure within 12 months
• No myocardial infarction (heart attack), severe/unstable angina (chest pain), coronary/peripheral artery bypass graft or stenting, cerebrovascular accident (stroke), or transient ischemic attack (temporary mini-stroke) within the past year
• No history of venous thrombosis (clots), pulmonary embolism (clot in lung), or hypercoagulopathy (blood clotting) syndrome
• No history of pulmonary hemorrhage, bleeding disorder or serious hemoptysis (coughing blood)
• No interstitial pneumonitis (lung inflammation) or pulmonary fibrosis (lung scarring) on baseline CT
• No abdominal fistula (abnormal opening of stomach/intestine), gastrointestinal perforation (hole), intra-abdominal abscess (infection), or serious or non-healing wound, ulcer, or bone fracture within the past 28 days
• At least 28 days since prior first-line therapy
• No more than one prior first-line chemotherapy regimen (platinum or non-platinum based) for NSCLC
• Prior adjuvant therapy allowed provided the patient received one regimen in the advanced setting
• At least 4 weeks since prior EGFR inhibitors or bevacizumab
• At least 28 days since prior major surgery (6 weeks since resection of brain metastases)
• At least 14 days since prior radiation therapy
• No prior pemetrexed disodium
• No prior VEGFR inhibitors (e.g., semaxanib, SU6668, AZ6474, sunitinib malate, vatalanib, cediranib, AEE-788, or sorafenib)
• No concurrent daily aspirin (> 325 mg/day) or non-steroidal anti-inflammatory agents known to inhibit platelet (blood clotting) function
• No concurrent dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal)

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ECOG 1505 (NCT00324805) For Stage IB to IIIA Completely Resected (surgically removed) Non-Small Cell Lung Cancer

Summary

A Phase III Randomized Trial of Adjuvant (in addition) Chemotherapy With or Without Bevacizumab (Avastin) for Patients With Completely Resected Stage IB to IIIA Non-Small Cell Lung Cancer (NSCLC)

This trial will evaluate overall survival using chemotherapy with or without bevacizumab used in the adjuvant setting.

Patients on their doctor’s choice of Vinorelbine and Cisplatin or Docetaxel and Cisplatin or Gemcitabine and Cisplatin or Pemetrexed and Cisplatin will be randomized to receive bevacizumab or not. Bevacizumab supplied at no charge.

Basic Eligibility Criteria:

• Must have undergone complete surgical resection (if stage IB tumor must be >4cm). Segmentectomy or wedge resection not allowed.
• Must be no less than 6 weeks and no more than 12 weeks after surgery
• Performance status 0 or 1
• Must not have received chemotherapy at any time
• Must not have received hormonal or radiation therapy for cancer within 5 years
• Must not have any history of cancer within 5 years except in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
• No history of active myocardial infarction (heart attack) or angina (chest pain) within 12 months
• No history of stroke (cerebral vascular accident-CVA) or transient ischemic attack (TIA- temporary mini-stroke)
• Must not be pregnant or breast-feeding
• Men and women must use adequate contraceptives during study treatment and for at least 6 months after completion of bevacizumab
• No serious active infection, symptomatic or uncontrolled congestive heart failure or symptomatic or uncontrolled cardiac arrhythmia (irregular heartbeat)
• No history of bleeding or blood clotting problems
• No serious non-healing wound, ulcer or bone fracture
• No major surgery, open biopsy or significant traumatic injury within 28 days or core biopsy within 7 days prior to randomization
• No history of abdominal fistula (hole between an abdominal organ to the skin's surface), GI (gastrointestinal) perforation or intra-abdominal abscess within 28 days
• No anticipated major surgical procedure during the study