MDACC Study Summary ACOSOGZ5041

Study Summary
No. ACOSOGZ5041:.......Pancreas......Jason B. Fleming......Surgical Oncology

Study Summary Title



Study Summary Number:	ACOSOGZ5041

Study Title:	A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Adenocarcinoma

Physician

New Patient Referral



Name:	Jason B. Fleming	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Surgical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6940 Contact us about clinical trials

General Information



Disease Group:	Pancreas	Supported By:	American College of Surgeons (ACOSOG) OSI Pharmaceuticals, A Member of the Astellas US group of companies

Phase of Study:	Phase II	Return Visit:	Days 1, 8, 15, 22, 29, 36 and 43 before surgery and days 1, 8, 15, 22, 29, 36 and 43 post surgery. Follow-up is every 3 months for 2 years and then every 6 months until year 4 or until disease relapse.

Treatment Agents:	Erlotinib Gemcitabine	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Standard for pancreatic surgery.


Description/ Intervention:	The goal of this clinical research study is to learn the effects of giving gemcitabine and erlotinib before and after surgery to remove pancreatic cancer. The safety of giving these study drugs before and after surgery will also be studied.

Study Objectives / Outcomes

Primary Objective
To estimate the proportion of patients alive at two years from the date of registration.

Secondary Objectives
To determine the resection rate (defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1)) following induction treatment with gemcitabine plus erlotinib.

To estimate the time to disease progression/relapse.

To evaluate the rate of R0, R1 and R2 resections in patients treated with preoperative gemcitabine plus erlotinib chemotherapy.

To evaluate the toxicity profile of preoperative gemcitabine plus erlotinib and the feasibility of postoperative gemcitabine plus erlotinib

To evaluate response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib.

To identify molecular predictors of pancreatic cancer response to gemcitabine combined with erlotinib.

To identify genetic profiles of pancreatic adenocarcinoma that may be associated with response to neoadjuvant therapy.

Study Status Information



Study Activation / Registration Date:	08/26/2009

IRB Review and Approval Date:	08/26/2009

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	123

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process.

2) Localized, potentially resectable tumors as defined below. All patients must be staged with a chest x-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or MRI. Radiological resectability is defined by the following criteria on abdominal imaging: a) No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery; b) No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence; c) No evidence of visceral or peritoneal metastases

3) Patients must be 18 years of age or older

4) ECOG/Zubrod performance status of 0 or 1

5) Patients with a baseline weight loss of less than or equal to 15% of premorbid weight

6) Patients must have adequate hematologic, renal, and hepatic function as defined by: WBC greater than or equal to 2,000 cells/mm^3; ANC greater than or equal to 1,500 cells/mm^3; Platelets greater than or equal to 100,000 cells/mm^3; Total serum bilirubin less than or equal to 2.5 mg/dL; Serum creatinine less than or equal to 1.5 mg/dL or a calculated creatinine clearance of greater than or equal to 50ml/min (24-hour urine collection); ALT less than 2.5 times ULN; AST less than 2.5 times ULN; Albumin greater than or equal to 3.2 g/dl

7) Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic greater than or equal to 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth-control while receiving study therapy.

Exclusion Criteria:

1) Patients with a history of the following: Prior EGFR targeted therapy or therapy for pancreatic cancer; Active infection requiring intravenous antibiotics at the time of registration

2) Patients with prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)

3) Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible.

4) Patients with tumors of the pancreatic neck, body or tail are not eligible. Patients with evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma are not eligible

Links

Registration Number: NCT00733746
Study Information on Clinical Trials Registry (clinicaltrials.gov)