Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer

NCT00253526 | Withdrawn Phase 2

• 3 other identifiers: CDR0000448825NCI-05-C-0158NCI-P6503
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage I Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer

Interventions

bevacizumab DRUG

gemcitabine hydrochloride DRUG

adjuvant therapy PROCEDURE

anti-cytokine therapy PROCEDURE

antiangiogenesis therapy PROCEDURE

antibody therapy PROCEDURE

biological therapy PROCEDURE

chemotherapy PROCEDURE

conventional surgery PROCEDURE

growth factor antagonist therapy PROCEDURE

monoclonal antibody therapy PROCEDURE

surgery PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * No evidence of distant metastasis on laparoscopy * No superior mesenteric artery or thrombosed superior mesenteric vein involvement * Superior mesenteric vein or portal vein involvement allowed * Evidence of a pancreatic mass by radiographic or endoscopic examination PATIENT CHARACTERISTICS: Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 2,500/mm\^3 * Absolute neutrophil count ≥ 1,250/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Hepatitis B surface antigen negative * Hepatitis C virus negative * No history of hepatic cirrhosis Renal * Creatinine ≤ 2.0 mg/dL * Proteinuria negative or trace by urinalysis OR * Protein \< 1 g on 24 hr urine collection * No active gross hematuria Cardiovascular * No severe congestive heart failure * No active ischemic heart disease * No ischemic changes on a cardiac thallium stress test * No uncontrolled hypertension (i.e., blood pressure ≤ 150/100 mm Hg despite antihypertensive therapy) * No active coagulation disorder Pulmonary * No active gross hemoptysis Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during the adjuvant therapy part of trial * HIV negative * No active infection * No wound healing problem from recent invasive procedure * No significant history of medical illness that would preclude patient from undergoing an operative procedure * No other malignancy requiring systemic therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Recovered from prior immunotherapy for pancreatic cancer * No prior bevacizumab Chemotherapy * Recovered from prior chemotherapy for pancreatic cancer * No prior gemcitabine hydrochloride Endocrine therapy * Recovered from prior hormonal therapy for pancreatic cancer Radiotherapy * Recovered from prior radiotherapy for pancreatic cancer * No prior radiotherapy to the pancreas Surgery * No prior definitive resection of the primary pancreatic tumor * Prior surgery, other than resection of the primary tumor, allowed Other * More than 3 weeks since prior systemic therapy for this cancer * No concurrent therapeutic anticoagulation causing elevated PT or PTT

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Gemcitabine; Chemotherapy, Adjuvant; Immunization, Passive; Biological Therapy; Drug Therapy; Antibodies, Monoclonal; Surgical Procedures, Operative

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; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Immunization; Immunotherapy; Immunomodulation; Immunologic Techniques; Investigative Techniques

Study Officials

• Richard E. Royal, MD, FACS

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Last Updated: April 28, 2015

Record last verified: 2006-12