Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer

NCT00100815 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000409556RPCI-I-19903GENENTECH-RPCI-I-19903
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

  every 2-4 months for 1 year and then every 6 months for 5 years

Secondary Outcomes (4)

• Percentage of Participants With Grades 3-5 Treatment Related Toxicities

  Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years

• Percentage of Participants With Improved Quality of Life

  assessed at baseline then weekly for 3 weeks

• Clinical Response

  Pre-treatment and every 6 weeks from treatment.

• Overall Survival

  every 2-4 months for 1 year and then every 6 months for 5 years

Interventions

bevacizumab BIOLOGICAL

30-90 minutes on day 1, every 21 days up to 12 months.

capecitabine DRUG

twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

gemcitabine hydrochloride DRUG

IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas meeting 1 of the following criteria: * Newly diagnosed or previously treated metastatic disease * Unresectable disease * No CNS or brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * WBC \> 3,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed) * No evidence of bleeding diathesis or coagulopathy Hepatic * Bilirubin \< 2 mg/dL * AST or ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * INR \< 1.5 (except for patients receiving full-dose warfarin) Renal * Creatinine \< 1.5 mg/dL * No proteinuria OR * Urine protein \< 500 mg by 24-hour urine collection * No clinically significant impairment of renal function Cardiovascular * No uncontrolled hypertension (blood pressure \> 160/110 mm Hg on medication) * No New York Heart Association class II-IV congestive heart failure * No unstable symptomatic arrhythmia requiring medication * Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed * No clinically significant grade II-IV peripheral vascular disease * No arterial thromboembolic event within the past 6 months, including any of the following: * Transient ischemic attack * Cerebrovascular accident * Unstable angina * Myocardial infarction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious systemic disease * No significant traumatic injury within the past 28 days * No serious non-healing wound, ulcer, or bone fracture * No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * More than 28 days since prior major surgery or open biopsy * More than 7 days since prior fine needle aspirations or core biopsies * No concurrent major surgery Other * More than 4 weeks since prior and no concurrent participation in any other experimental drug study * More than 12 months since prior adjuvant therapy * No prior systemic therapy for metastatic disease

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

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-1714, United States

Location

Related Publications (1)

• Javle M, Yu J, Garrett C, Pande A, Kuvshinoff B, Litwin A, Phelan J 3rd, Gibbs J, Iyer R. Bevacizumab combined with gemcitabine and capecitabine for advanced pancreatic cancer: a phase II study. Br J Cancer. 2009 Jun 16;100(12):1842-5. doi: 10.1038/sj.bjc.6605099. Epub 2009 Jun 2.

  PMID: 19491904 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Capecitabine; 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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Renuka Iyer, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 6, 2005
• First Posted: January 7, 2005
• Study Start: August 1, 2004
• Primary Completion: August 1, 2008
• Last Updated: December 24, 2015
• Results First Posted: December 24, 2015

Record last verified: 2015-11

Locations

US (2)