Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Brief summary public domain (ClinicalTrials.gov)

PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

Detailed description public domain (ClinicalTrials.gov)

This is a single arm, non-randomized phase II study. Eligible, fully registered patients will receive preoperative chemotherapy consisting of gemcitabine plus erlotinib. Preoperative chemotherapy will be followed by exploratory laparotomy and pancreaticoduodenectomy. Patients will then receive postoperative chemotherapy consisting of gemcitabine plus erlotinib. Up to 123 patients will be accrued to this study, with the expectation that 78 patients will remain fully eligible and evaluable for the primary endpoint. The primary and secondary objectives for the study are listed below. Primary Objective: To estimate the proportion of patients alive at two years from the date of registration Secondary Objectives: 1. To determine the resection rate (defined as the fraction of patients who proceed to planned surgery with removal of primary tumor \[R0/R1\]) following induction treatment with gemcitabine plus erlotinib 2. To estimate the time to disease progression/relapse 3. To evaluate the rate of R0, R1, and R2 resections (defined as per the 6th edition of the AJCC Cancer Staging Manual) in patients treated with preoperative gemcitabine plus erlotinib chemotherapy 4. To evaluate the toxicity profile of preoperative gemcitabine plus erlotinib and the feasibility of postoperative gemcitabine plus erlotinib 5. To evaluate response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib 6. To identify molecular predictors of pancreatic cancer response to gemcitabine combined with erlotinib 7. To identify genetic profiles of pancreatic adenocarcinoma that may be associated with response to neoadjuvant therapy After completion of postoperative chemotherapy treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.

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

Overall Survival at 2 Years [At 2 years post-registration]. Number, proportion of patients (95% Confidence Interval). Neoadjuvant Therapy + Surgery + Adjuvant Therapy (n=74): 0.54 (0.42 to 0.66).

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

Resection Rate [Up to 4 years postoperative chemotherapy treatment]. Geometric Least Squares Mean, proportion of patients (95% Confidence Interval). Neoadjuvant Therapy + Surgery + Adjuvant Therapy (n=97): 0.76 (0.67 to 0.84).

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

Relapse/Progression-free Survival [At 2 years post-registration]. Median, months (95% Confidence Interval). Neoadjuvant Therapy + Surgery + Adjuvant Therapy (n=74): 11.9 (10.8 to 17.5).

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

Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events [Up to 4 years postoperative chemotherapy treatment]. Count Of Participants, Participants. Grade 3+ Adverse Event: Neoadjuvant Therapy + Surgery + Adjuvant Therapy (n=119): 27. Grade 4+ Adverse Event: Neoadjuvant Therapy + Surgery + Adjuvant Therapy (n=119): 2.

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

Response Rate [Up to 4 years postoperative chemotherapy treatment]. Number, proportion of patients (95% Confidence Interval). Neoadjuvant Therapy + Surgery + Adjuvant Therapy (n=97): 0.06 (0.02 to 0.13).