Trial record 1 of 1 for:    ACOSOG Z5041
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Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
OSI Pharmaceuticals
Astellas Pharma Inc
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00733746
First received: August 12, 2008
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival at 2 years [ Time Frame: At 2 years post-registration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resection rate [ Time Frame: Up to 4 years postoperative chemotherapy treatment ] [ Designated as safety issue: No ]
  • Relapse/progression-free survival [ Time Frame: At 2 years post-registration ] [ Designated as safety issue: No ]
  • Adverse event profile [ Time Frame: Up to 4 years postoperative chemotherapy treatment ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: Up to 4 years postoperative chemotherapy treatment ] [ Designated as safety issue: No ]
  • Molecular and genetic profiles [ Time Frame: Up to 4 years postoperative chemotherapy treatment ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: April 2009
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant therapy + Surgery + Adjuvant therapy
As part of neoadjuvant therapy, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of neoadjuvant therapy, patients undergo pancreaticoduodenectomy and patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post surgery.
Drug: erlotinib hydrochloride
oral administration
Drug: gemcitabine hydrochloride
Intravenous administration
Procedure: therapeutic conventional surgery

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

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

    NOTE: 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.

  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:

    • No evidence of tumor extension to the celiac axis, hepatic artery, or superior mesenteric artery
    • No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
    • No evidence of visceral or peritoneal metastases

    NOTE: Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible. Patients must meet all objective imaging criteria outlined above.

  3. ≥ 18 years of age
  4. ECOG/Zubrod performance status of 0 or 1
  5. Baseline weight loss ≤ 15% of premorbid weight
  6. Patient must have adequate hematologic, renal, and hepatic function as defined by:

    • WBC ≥ 2,000 cells/mm³
    • ANC ≥ 1,500 cells/mm³
    • Platelets ≥ 100,000 cells/mm³
    • Serum bilirubin ≤ 2.5 mg/dL
    • Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 50 ml/min (24 hour urine collection)
    • ALT < 2.5 times upper limit of normal (ULN)
    • AST < 2.5 times ULN
    • Albumin ≥ 3.2 g/dl
  7. No history of the following:

    • Prior EGFR targeted therapy or therapy for pancreatic cancer
    • Active infection requiring intravenous antibiotics at the time of registration
  8. 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 ≥ 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.
  9. No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733746

  Show 24 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
OSI Pharmaceuticals
Astellas Pharma Inc
Investigators
Study Chair: Peter W.T. Pisters, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00733746     History of Changes
Other Study ID Numbers: CDR0000609871, ACOSOG-Z5041, U10CA076001, NCI-2009-00348
Study First Received: August 12, 2008
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration
United States: NCI Central Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Erlotinib
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014