Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

NCT00524069 | Withdrawn

• 2 other identifiers: I 68805RPCI-I-68805
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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 and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with pancreatic cancer that can be removed by surgery.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Feasibility and safety

• Margin status after pancreatic resection

Secondary Outcomes (8)

• Proportion of patients with positive resection margins, including microscopic (R1) or gross (R2) positive resection margins

• Median survival

• Time to recurrence

• Overall survival

• Number of circulating endothelial precursor cells (CEC) and their VEGFR expression as measured by flow cytometry at baseline and after the start of neoadjuvant therapy

Interventions

bevacizumab BIOLOGICAL

capecitabine DRUG

gemcitabine hydrochloride DRUG

flow cytometry OTHER

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

computed tomography PROCEDURE

neoadjuvant therapy 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 pancreatic adenocarcinoma * Resectable disease (i.e., stage I or II disease) * No unresectable (i.e., locally advanced) disease * No tumor invasion into the stomach or duodenum * No CNS, brain, or systemic metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC \> 3,000/μL * ANC \> 1,500/μL * Platelet count \> 100,000/μL * Total bilirubin \< 2 mg/dL * AST or ALT \< 2.5 times upper limit of normal (ULN) * Creatinine \< 1.5 mg/dL * Creatinine clearance ≥ 50 mL/min * Urine protein:creatinine ratio \< 1.0 * Hemoglobin ≥ 9 g/dL (transfusion, epoetin alfa, or darbepoetin allowed) * INR \< 1.5 times ULN (except in patients receiving full-dose warfarin) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled hypertension * No unstable angina * No New York Heart Association class II-IV congestive heart failure * No myocardial infarction or stroke within the past 6 months * No clinically significant peripheral vascular disease * No evidence of bleeding diathesis or coagulopathy * No significant traumatic injury within the past 28 days * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No esophageal or gastric varices * No serious nonhealing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: * No prior therapy for pancreatic cancer * More than 4 weeks since prior and no concurrent participation in another experimental drug study * More than 28 days since prior major surgical procedure or open biopsy * More than 7 days since prior minor surgical procedure (e.g., fine-needle aspiration or core biopsy)

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Capecitabine; Gemcitabine; Flow Cytometry; Chemotherapy, Adjuvant; Neoadjuvant Therapy

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Renuka Iyer, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2007
• Last Updated: February 1, 2013

Record last verified: 2013-01