Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas

NCT00003797 | Unknown Phase 2

• 3 other identifiers: CDR0000066940BRUOG-PA-77NCI-T98-0067
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage IV pancreatic cancer

Interventions

trastuzumab BIOLOGICAL

gemcitabine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven metastatic pancreatic cancer with overexpression of HER2/neu * Patients in whom there is inadequate tissue to evaluate for HER2/neu overexpression but who have elevated serum HER2/neu antigen levels are eligible * Radiographically measurable disease * May have metastatic disease in which primary lesion is measurable but metastatic lesions are not measurable * Ascites is not measurable PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 3.0 mg/dL * Greater than 3 times normal if increase in bilirubin is due to biliary obstruction from tumor as long as biliary system is stented or bypassed and bilirubin, SGOT, or SGPT is stable or decreasing * SGOT no greater than 3 times normal * No greater than 5 times normal if liver metastases present OR * Greater than 5 times normal if increase in SGOT or SGPT is due to biliary obstruction from tumor as long as biliary system is stented or bypassed and biliary SGOT or SGPT is stable or decreasing Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No unstable angina * No prior congestive heart failure * No prior myocardial infarction * LVEF at least 45% by MUGA or echocardiogram Other: * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior trastuzumab * No concurrent growth factors Chemotherapy: * No prior anthracyclines * No prior gemcitabine except prior low dose (no greater than 300 mg/m2/week) gemcitabine with radiotherapy * At least 6 months since prior adjuvant therapy * More than 2 weeks since other prior chemotherapy * No other concurrent cytotoxic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Chemotherapy * More than 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent investigational agents

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

Sponsors & Collaborators

• Brown University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135-2997, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Roger Williams Medical Center/BUSM

Providence, Rhode Island, 02908-4735, United States

Location

Brown University Oncology Group

Providence, Rhode Island, 02912, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Trastuzumab; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Howard Safran, MD

  Brown University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 2, 2003
• Study Start: March 1, 1999
• Last Updated: December 19, 2013

Record last verified: 2002-12

Locations

US (12)