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

NCT00733746 | Completed Phase 2 Results DMC

• 4 other identifiers: ACOSOG-Z5041U10CA076001NCI-2009-00348CDR0000609871
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 24

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 2 Years

  The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.

  At 2 years post-registration

Secondary Outcomes (4)

• Resection Rate

  Up to 4 years postoperative chemotherapy treatment

• Relapse/Progression-free Survival

  At 2 years post-registration

• 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

• Response Rate

  Up to 4 years postoperative chemotherapy treatment

Study Arms (1)

Neoadjuvant therapy + Surgery + Adjuvant therapy

EXPERIMENTAL

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; Drug: gemcitabine hydrochloride; Procedure: therapeutic conventional surgery

Interventions

erlotinib hydrochloride DRUG

oral administration

Neoadjuvant therapy + Surgery + Adjuvant therapy

gemcitabine hydrochloride DRUG

Intravenous administration

Neoadjuvant therapy + Surgery + Adjuvant therapy

therapeutic conventional surgery PROCEDURE

Neoadjuvant therapy + Surgery + Adjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• OSI Pharmaceuticals: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (24)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

St. Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

Location

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

St. Francis Hospital Cancer Care Services

Indianapolis, Indiana, 46237, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

St. Agnes Hospital Cancer Center

Baltimore, Maryland, 21229, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

CCOP - Dayton

Dayton, Ohio, 45420, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Surgical Oncology Associates

Newport News, Virginia, 23606, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Peter Pisters, MD
• Organization: Alliance for Clinical Trials in Oncology

ppisters@mdanderson.org

Study Officials

• Peter W.T. Pisters, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 13, 2008
• Study Start: April 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: June 15, 2019
• Last Updated: October 21, 2019
• Results First Posted: May 8, 2017

Record last verified: 2019-10

Locations

CA (1); US (23)