Results of the X-PECT study: A phase III randomized double-blind placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. LBA3501-LBA3501
Author(s):  
Johanna C. Bendell ◽  
Thomas J. Ervin ◽  
Neil N. Senzer ◽  
Donald A. Richards ◽  
Irfan Firdaus ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Annual Meeting ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Daily News ◽  
Double Blind Placebo ◽  
Online Supplement ◽  
Final Text

LBA3501 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

Bevacizumab (BEV) plus chemotherapy (CT) continued beyond first progression in patients with metastatic colorectal cancer (mCRC) previously treated with BEV plus CT: Results of a randomized phase III intergroup study (TML study).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. CRA3503-CRA3503 ◽  
Author(s):  
Dirk Arnold ◽  
Thierry Andre ◽  
Jaafar Bennouna ◽  
Javier Sastre ◽  
Pia J. Osterlund ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Phase Iii ◽  
Daily News ◽  
Online Supplement ◽  
Previously Treated ◽  
Final Text

CRA3503 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

RTOG 0825: Phase III double-blind placebo-controlled trial evaluating bevacizumab (Bev) in patients (Pts) with newly diagnosed glioblastoma (GBM).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
Mark R. Gilbert ◽  
James Dignam ◽  
Minhee Won ◽  
Deborah T. Blumenthal ◽  
Michael A. Vogelbaum ◽  
...  
Keyword(s):  
Annual Meeting ◽  
Controlled Trial ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Double Blind ◽  
Daily News ◽  
Double Blind Placebo ◽  
Online Supplement ◽  
Newly Diagnosed Glioblastoma ◽  
Final Text

1 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Sunday, June, 2, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

Patient preference between pazopanib (Paz) and sunitinib (Sun): Results of a randomized double-blind, placebo-controlled, cross-over study in patients with metastatic renal cell carcinoma (mRCC)—PISCES study, NCT 01064310.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. CRA4502-CRA4502 ◽  
Author(s):  
Bernard J. Escudier ◽  
Camillo Porta ◽  
Petri Bono ◽  
Ugo De Giorgi ◽  
Omi Parikh ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Annual Meeting ◽  
Patient Preference ◽  
Renal Cell ◽  
Double Blind ◽  
Daily News ◽  
Double Blind Placebo ◽  
Online Supplement ◽  
Final Text

CRA4502 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.

Randomized comparison of FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment of KRAS-wildtype metastatic colorectal cancer: German AIO study KRK-0306 (FIRE-3).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. LBA3506-LBA3506
Author(s):  
Volker Heinemann ◽  
Ludwig Fischer von Weikersthal ◽  
Thomas Decker ◽  
Alexander Kiani ◽  
Ursula Vehling-Kaiser ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Line Treatment ◽  
First Line ◽  
Daily News ◽  
Online Supplement ◽  
Final Text ◽  
First Line Treatment

LBA3506 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Saturday June, 1, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.

CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. CRA9013-CRA9013
Author(s):  
Ellen M. Lavoie Smith ◽  
Herbert Pang ◽  
Constance Cirrincione ◽  
Stewart Barry Fleishman ◽  
Electra D. Paskett ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Phase Iii ◽  
Double Blind Trial ◽  
Double Blind ◽  
Daily News ◽  
Online Supplement ◽  
Blind Trial ◽  
Final Text

CRA9013 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Monday, June 4, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.

Results of the X-PECT study: A phase III randomized double-blind, placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA3501-LBA3501 ◽  
Author(s):  
Johanna C. Bendell ◽  
Thomas J. Ervin ◽  
Neil N. Senzer ◽  
Donald A. Richards ◽  
Irfan Firdaus ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Phase Ii ◽  
Median Overall Survival ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Phase Ii ◽  
Phase Iii Study

LBA3501 Background: Perifosine (P) is an oral, synthetic alkylphospholipid that inhibits or modifies signal transduction pathways including AKT, NFkB and JNK. A randomized phase II study examined P-CAP vs. CAP in pts with 2nd or 3rd line mCRC. This study showed improvement in mTTP (HR 0.254 [0.117, 0.555]) and mOS (HR 0.370 [0.180,0.763]). Based on these results, a randomized phase III study of P-CAP vs. CAP with a primary endpoint of overall survival (OS) in pts with refractory mCRC was initiated. Methods: The study was a prospective, randomized, double-blind, placebo-controlled randomized phase III trial. Eligible pts had mCRC which was refractory to all standard therapies. Pts randomized 1:1 to Arm A = P-CAP (P 50 mg PO QD + CAP 1000 mg/m2PO BID d1-14) or Arm B = CAP (placebo + CAP 1000 mg/m2 PO BID d 1-14). Cycles were 21 days. Baseline tumor block collection and a biomarker cohort of pts with pre- and on-treatment tumor and blood samples were performed. Results: Between 3/31/10 and 8/12/11, 468 pts were randomized, 234 pts were in each arm. Baseline demographics were balanced between the arms: age < 65y (A: 65%, B: 58.5%), male (A: 57.7%, B: 53.0%), ECOG PS 0 (A: 39.7%, B: 39.7%), K-ras mutant (A: 50.4%, B: 51.3%), and median number of prior therapies (A: 4, B: 4). As of 3/19/12, median follow up was 6.6 months. Median overall survival: Arm A = 6.4 mo, Arm B = 6.8 mo, HR 1.111 [0.905,1.365], p = 0.315. Median overall survival for K-ras WT pts: Arm A = 6.6 mo, Arm B = 6.8 mo, HR 1.020 [0.763,1.365], p = 0.894; K-ras mutant pts: Arm A = 5.4 mo, Arm B = 6.9 mo HR 1.192 [0.890,1.596], p = 0.238. Conclusions: Despite promising randomized phase II data, this phase III study shows no benefit in overall survival adding perifosine to capecitabine in the refractory colorectal cancer setting. Response rate, progression free survival, and safety data will be presented. Biomarker analysis is pending to see if subgroups of patients may have potential benefit.

AURELIA: A randomized phase III trial evaluating bevacizumab (BEV) plus chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer (OC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. LBA5002-LBA5002 ◽  
Author(s):  
Eric Pujade-Lauraine ◽  
Felix Hilpert ◽  
Béatrice Weber ◽  
Alexander Reuss ◽  
Andres Poveda ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Recurrent Ovarian Cancer ◽  
Phase Iii ◽  
Daily News ◽  
Phase Iii Trial ◽  
Online Supplement ◽  
Final Text

LBA5002^ The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.

Bevacizumab (Bev) with or without erlotinib as maintenance therapy, following induction first-line chemotherapy plus Bev, in patients with metastatic colorectal cancer (mCRC): Efficacy and safety results of the international GERCOR DREAM phase III trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. LBA3500-LBA3500
Author(s):  
Christophe Tournigand ◽  
Benoit Samson ◽  
Werner Scheithauer ◽  
Gérard Lledo ◽  
Frédéric Viret ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Maintenance Therapy ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
First Line ◽  
Daily News ◽  
Phase Iii Trial ◽  
Online Supplement ◽  
Final Text ◽  
Line Chemotherapy

LBA3500^ The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

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