ChemoRT With Adjuvant Chemo in Pancreatic Cancer (TARCEVA)

Brief summary public domain (ClinicalTrials.gov)

To seek preliminary evidence of antitumor activity (progression free survival) of Erlotinib in combination with standard adjuvant chemoradiation and chemotherapy in patients with resected adenocarcinoma of the pancreas.

Detailed description public domain (ClinicalTrials.gov)

This study is a phase II trial of erlotinib in combination with chemoradiation in patients with stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. This study is a phase II trial of erlotinib in combination with chemoradiation in patients with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off) and External Beam Radiation Therapy (EBRT) to the tumor bed plus adjacent lymph nodes at doses of 50.4 Gy in 28 fractions after surgery. For patients with close or positive margins after resection, they will be able to receive 54.0 Gy over 30 fractions. Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus erlotinib 100 mg/daily.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Recurrence Free Survival [Up to 3 years]. Median, months (95% Confidence Interval). Erlotinib and EBRT After Pancreatectomy (n=48): 15.6 (13.4 to 17.9).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants Experiencing Adverse Events [up to 3 years]. Count Of Participants, Participants. Grade 2: Chemoradiation Plus Erlotinib (n=48): 24; Adjuvant Gemcitabine Plus Erlotinib (n=39): 15. Grade 3: Chemoradiation Plus Erlotinib (n=48): 15; Adjuvant Gemcitabine Plus Erlotinib (n=39): 14. Grade 4: Chemoradiation Plus Erlotinib (n=48): 1; Adjuvant Gemcitabine Plus Erlotinib (n=39): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) [Up to 3 months after completion of maintenance chemotherapy]. Mean, score on a scale (Full Range). Global (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 1 (-6.5 to 8.5). Global (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -1.8 (-8.1 to 4.5). Global (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): 4.6 (-3.3 to 12.6). Functional (F) - Physical (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 0.5 (-4.8 to 5.8). F - Physical (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -3.2 (-8.8 to 2.3). F - Physical (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): -6.2 (-11 to 1.5). F - Role (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -3.1 (-13.5 to 7.2). F - Role (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -0.3 (-13.5 to 12.9). F - Role (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): -4.4 (-15.5 to 6.7). F - Cognition (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -2.6 (-7.4 to 2.2). F - Cognition (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 1.2 (-6.6 to 9.1). F - Cognition (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): -1.2 (-8.3 to 5.8). F - Emotional (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -0.4 (-5.3 to 4.4). F - Emotional (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 2.2 (-5.2 to 9.6). F - Emotional (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): -0.6 (-9.1 to 7.9). F - Social (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 3.9 (-5.4 to 13.1). F - Social (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 4.4 (-5.7 to 14.5). F - Social (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): -3.8 (-14.2 to 6.7). Financial (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 1.7 (-4.3 to 7.6). Financial (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 2.5 (-2.7 to 7.7). Financial (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): 0 (-7.6 to 7.6). General Symptoms (GS) - Fatigue (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 5.7 (-1.1 to 12.4). GS - Fatigue (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 5.2 (-2.1 to 12.5). GS - Fatigue (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): 1.7 (-6.2 to 9.5). GS - Nausea/Vomiting (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 2.5 (-2.9 to 7.9). GS - Nausea/Vomiting (Time 2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 0 (-7.4 to 7.4). GS - Nausea/Vomiting (Time 2 vs. Time 1): Erlotinib and EBRT After Pancreatectomy (n=33): 1.9 (-5.3 to 9). GS - Pain (Time 1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 2.7 (-4.9 to 10.3). GS - Pain (Time 2 vs. BL): Erlotinib and EBRT

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in QoL as Assessed by QLQ-PAN 26 [3 months]. Mean, score on a scale (Full Range). Pancreatic Pain (t1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -1.9 (-6.8 to 3). Pancreatic Pain (t2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -3.8 (-11.7 to 4.1). Pancreatic Pain (t2 vs. t1): Erlotinib and EBRT After Pancreatectomy (n=33): 2.4 (-4.3 to 9.2). Digestive (t1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -0.9 (-9.1 to 7.3). Digestive (t2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -4.6 (-13.6 to 4.4). Digestive (t2 vs. t1): Erlotinib and EBRT After Pancreatectomy (n=33): -1.4 (-7.4 to 4.6). Altered Bowel Habits (t1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 14.7 (6 to 23.5). Altered Bowel Habits (t2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 7.2 (-2.7 to 17.1). Altered Bowel Habits (t2 vs. t1): Erlotinib and EBRT After Pancreatectomy (n=33): -4.9 (-12 to 2.3). Jaundice (t1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -1.3 (-6.7 to 4). Jaundice (t2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -2 (-12.1 to 8.1). Jaundice (t2 vs. t1): Erlotinib and EBRT After Pancreatectomy (n=33): 0 (-5.2 to 5.2). Body Image (t1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -6.2 (-13.2 to 0.7). Body Image (t2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -3.1 (-10.7 to 4.4). Body Image (t2 vs. t1): Erlotinib and EBRT After Pancreatectomy (n=33): -0.7 (-10.2 to 8.9). Satisfaction with healthcare (t1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 4.1 (-5.8 to 13.9). Satisfaction with health care (t2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 3.1 (-12.3 to 18.5). Satisfaction with health care (t2 vs. t1): Erlotinib and EBRT After Pancreatectomy (n=33): 0 (-11.4 to 11.4). Sexual function (t1 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): -0.5 (-10.8 to 9.7). Sexual function (t2 vs. BL): Erlotinib and EBRT After Pancreatectomy (n=33): 14.7 (2.6 to 26.8). Sexual function (t2 vs. t1): Erlotinib and EBRT After Pancreatectomy (n=33): 14.1 (3 to 25.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Death as Assessed by Median Overall Survival (Months) [up to 5 years]. Median, months (95% Confidence Interval). Erlotinib and EBRT After Pancreatectomy (n=48): 24.39 (18.87 to 29.65).