SWOG clinical trial number
S0536
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
Abbreviated Title
Phase II Carboplatin, Paclitaxel, Cetuximab and Bevacizumab in Adv. NSCLC
Treatment
Paclitaxel
Carboplatin
Bevacizumab
Cetuximab
Pts must have histologic or cytologically confirmed NSCLC, adeno, large cell, or unspecified, Stage IIIB with pleural effusion or IV, advanced or recurrent after previous surgery and/or irradiation. Pts must not have tumors with > 50% squamous cell carcinoma components. No Prior systemic chemo, adjuvant, or bio therapy for NSCLC. No symptomatic neuropathy-sensory > Grade 2. No other prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission; disease-free from any ca for 5 years. Pts must have measurable or non-measurable disease by CT. Pleural effusion, ascites and lab parameters are not acceptable as the only evidence of disease. Pts may have prior radiation > 3wks since completion and must be recovered from tox at registration. Pts must not have: history (w/i 6 months) of CVA, MI, unstable angina, uncontrolled HTN, CHF > Grade 2 (NY Heart Ass.), serious cardiac arrhythmia requiring medication, clinically significant PVD. Pts must not have: Open bx or significant traumatic injury w/i 28 days, core bx w/i 7 days; non healing wound; ulcer or bone fx; h/o abdominal fistula; GI perforation or intra-abdominal abscess w/i 28 days; evidence of bleeding diathesis or coagulopathy; acute hepatitis or active or uncontrolled infection. Pts must have UPC <0.5, or if > 0.5; 24 hr urine protein <1000mg; serum creat < IULN AND calc/meas creat clear > 50cc/min. Pts must have adequate hepatic function: bili, SGOT or SGPT and alk phos <2 x IULN; adequate renal function: serum creat < IULN AND calc or measured creat clearance > 50 ml/min. (See formula Section 5.9) ANC>1,5000 and platelet >100,000. For GMP: Hgb > 9 mg/dl. No prior treatment with cetuximab, erlotinib, ZD1839 (gefitinib), or other agents that target the EGFR pathway. No treatment w/VEGF-related agents. Pts may not have received prior chimerized or murine monoclonal antibody therapy or have presence of human anti-mouse antibodies (HAMA). No known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies. Pts must have INR < 1.5 if not on full dose anticoagulation. No active bleeding or pathologic condition that carries a high risk of bleeding. Pts may be on low-dose warfarin. No brain mets. Pts must have recovered from sx at least 4 wks prior. No pregnant or nursing women. Pts must have PS 0-1, 18 years or older, willing to submit prior smoking history. Pts must not be on full-dose anticoagulation.
2010
Patient selection for cetuximab in NSCLC: A systematic review of candidate predictive biomarkers
J Harbison;D Horak;S Maier;TJ Lynch;D Gandara;KJ O'Byrne;R Pirker;M Weber;S Khambata-Ford Journal of Clinical Oncology 28:15s (suppl; abstr 7548); ASCO annual meeting; poster
2009
Expression of EGFR protein and markers of epithelial-mesenchymal transformation (DMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC)
WA Franklin;DR Gandara;ES Kim;RS Herbst;J Moon;M Redman;C Olsen;FR Hirsch;P Mack;K Kelly Journal of Clinical Oncology 27:15s, abst. #11076
KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536
PC Mack;WS Holland;M Redman;P Lara;LJ Snyder;FR Hirsch;WA Franklin;ES Kim;RS Herbst;DR Gandara Journal of Clinical Oncology 27:15s, abst. #8022
Carboplatin, paclitaxel, cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC), a SWOG phase II study
DR Gandara;ES Kim;RS Herbst;J Moon;M Redman;SR Dakhil;F Hirsch;PC Mack;WA Franklin;K Kelly Journal of Clinical Oncology 27:15s, abst.#8015
S0536: Carboplatin, paclitaxel, cetuximab and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC), a SWOG phase II study
ES Kim;RS Herbst;J Moon;M Redman;S Dakhil;F Hirsch;P Mack;W Franklin;K Kelly;DR Gandara Journal of Thoracic Oncology 4(9):suppl 1, abst. #PD3.5.5, S455; IASLC 13th World Conf on Lung Cancer, oral;
2008
S0536 SWOG phase II trial of carboplatin (c), paclitaxel (P), cetuximab (CX) and bevacizumab (B) followed by cetuximab and bevacizumab in advanced non-small cell lung cancer (NSCLC)
ES Kim;RS Herbst;J Moon;J Crowley;M Redman;SR Dakhil;JL Wade;K Kelly;GR Gandara Journal of Thoracic Oncology 3(11) supp. 4:S266, abst. #9
Cooperative group research efforts in lung cancer 2008: focus on advanced-stage non-small-cell lung cancer
H Wakelee;K Kernstine;E Vokes;J Schiller;P Baas;N Saijo;A Adjei;G Gross;L Gaspar;D Gandara;H Choy;JB Putnam Clinical Lung Cancer 9(6):345-351
PMid: PMID19073517 | PMC number: (Reviews are not within the scope of the Public Access)
