Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: * Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas. * Determine the time to progression and overall survival of patients treated with these regimens. * Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm A: Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1, 8, 15, and 22. * Arm B: Patients receive docetaxel and irinotecan as in arm A. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter. PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm)

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

Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) [Assessed every 12 weeks until progression]. Number, Proportion of participants (90% Confidence Interval). Arm A: Irinotecan/Docetaxel (n=44): 0.045 (0.015 to 0.184); Arm B: Irinotecan/Docetaxel/Cetuximab (n=43): 0.07 (0.024 to 0.198).

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

Progression-free Survival [Assessed every 3 months for 2 years and then every 6 months for 1 year]. Median, months (90% Confidence Interval). Arm A: Irinotecan/Docetaxel (n=44): 3.9 (2.4 to 5.0); Arm B: Irinotecan/Docetaxel/Cetuximab (n=43): 4.5 (2.7 to 5.6).

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

Overall Survival [Assessed every 3 months for 2 years and then every 6 months for 1 year]. Median, months (90% Confidence Interval). Arm A: Irinotecan/Docetaxel (n=44): 6.5 (5.6 to 9.9); Arm B: Irinotecan/Docetaxel/Cetuximab (n=43): 5.3 (4.5 to 9.4).

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

Epidermal Growth Factor Receptor (EGFR) Status [Original tumor tissue samples submitted within one month of patient randomization]. Number, participants. Positive: Arm A: Irinotecan/Docetaxel (n=30): 29; Arm B: Irinotecan/Docetaxel/Cetuximab (n=31): 30. Negative: Arm A: Irinotecan/Docetaxel (n=30): 1; Arm B: Irinotecan/Docetaxel/Cetuximab (n=31): 1.

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

Proportion of Patients With Thromboembolic Events [Assessed every 6 weeks while on treatment and for 30 days after the end of treatment]. Number, Proportion of participants (90% Confidence Interval). Arm A: Irinotecan/Docetaxel (n=44): 0 (0.0 to 0.066); Arm B: Irinotecan/Docetaxel/Cetuximab (n=43): 0.023 (0.001 to 0.106).