Clinical Trials – Lung Cancer

Clinical Trials – Lung Cancer

Clinical Trials – Lung Cancer

LUNG PROTOCOLS: Non-small Cell
1. CALGB 30607
Stage IIIB/IV; Maintenance Therapy
Eligibility: pts must have received 4 cycles platinum based doublet therapy +/- bevacizumab; no evidence of progression; no prior adj chemo for stg I-III resected dz or combined modality Rx for stage III NSCLC; Rx: Sunitinib, 37.5 mg po daily versus Placebo. (SUNITINIB/PLACEBO SUPPLIED)

2. CTSU E1505
Completely Resected NSCLC
Eligibility: Stage IB – IIIA (If IB, tumor >/= 4 cm); wedge resection or segmentectomy NOT allowed; mediastinal lymph node sampling expected; no prior chemo; performance status 0-1; 6-12 weeks post-op: RX: One of 3 chemo regimens +/- Bevacizumab (Investigator may choose Cisplat/Vinorelbine or Cisplat/docetaxel or Cisplat/gemcitabine). (BEVACIZUMAB SUPPLIED)

3. SWOG 0819
Stage IV Newly Diagnosed or Recurrent
Eligibility: measurable or non-measurable dz; performance status 0-1; no prior chemo, cetuximab, gefitinib, erlotinib or agents that target EGFR pathway; no VEGF related agents; no chimerized or muring monoclonal antibody therapy; nodules in an ipsilateral non-primary lobe with no other M1 dz will not be considered stage IV: Rx: Chemo +/- Bevacizumab versus Chemo with Cetuximab +/- Bevacizumab (CETUXIMAB SUPPLIED)

4. SWOG S0709
Stage IIIB, IV or Recurrent NSCLC selected by Proteomic testing; PS = 2
Eligibility: newly dx Stage IIIB or IV or recurrent dz after surgery and/or irradiation; must submit blood sample for proteomic testing and have “VeriStrat positive” result to qualify for further study participation; Performance status must be 2; if prior RT, 14 days must elapse and recovery from side effects by registration; if prior adjuvant chemo, 1 yr must have elapsed since completion; no prior hormone, chemo or biologic tx for advanced NSCLC; measurable or non-measurable disease. RX: OSI-774 daily continuously versus OSI-774 + Carboplatin + Paclitaxel x 4 cycles, followed by OSI-774 daily continuously. (OSI-774 SUPPLIED)

LUNG PROTOCOLS: Small Cell

1. CALGB 30504 (Permanent accrual closure effective: 12/13/11)
Untreated Extensive Stage Disease
Eligibility: must have measurable disease; no prior chemo for SCLC; prior RT okay; performance status 0 – 2; no brain mets; Rx: Cisplatin or Carbo + Etoposide q 21 days for up to 6 cycles. After a min of 4 cycles patients with responding or stable dz are randomized to sunitinib/placebo. Those on placebo crossover to Sunitinib at progression.
(SUNITINIB/PLACEBO & SUNITINIB OPEN LABEL SUPPLIED)

2. CALGB 30610
Limited Stage
Eligibility: No prior resection; no prior chemo or RT for SCLC; no prior thoracic RT; measurable or non-measurable dz; performance status 0-2; RX: Cisplatin/Etoposide X 4 cycles plus one of three radiotherapy regimens (3 arm study). (NO DRUG SUPPLIED)

LUNG PROTOCOLS: Small Cell
1. CALGB 30610
Limited Stage
Eligibility: No prior resection; no prior chemo or RT for SCLC; no prior thoracic RT; measurable or non-measurable dz; performance status 0-2; RX: Cisplatin/Etoposide X 4 cycles plus one of three radiotherapy regimens (3 arm study). (NO DRUG SUPPLIED)

Abbreviations:
CALGB = Cancer and Leukemia Group B
CTSU = Cancer Trials Support Unit
ECOG = Eastern Cooperative Oncology Group
NCI = National Cancer Institute
NSABP = National Surgical Adjunct Breast and Bowel Project
RTOG = Radiation Therapy Oncology Group
SCUSF = SunCoast CCOP Research Base
SWOG = Southwest Oncology Group
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