A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer

This study has been terminated.
(Terminated due to slow accrual)
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01025570
First received: December 1, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine, Bosutinib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer. [ Time Frame: 8 weeks after the 6th patient is enrolled ] [ Designated as safety issue: Yes ]
  • To estimate the median disease-free survival rate of patients with completely resected pancreatic cancer treated with this combination [ Time Frame: 2 years after last patient is enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the overall survival rates of patients with completely resected pancreatic cancer when treated postoperatively with the combination of gemcitabine and bosutinib [ Time Frame: 2 years after last patient is enrolled ] [ Designated as safety issue: No ]
  • To estimate both disease-free and overall survival at one and two years of patients with completely resected pancreatic cancer treated with this combination [ Time Frame: 2 years after last patient is enrolled ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gem/Bos

Gemcitabine 1000 mg/m2, D1,8,15 of each cycle

Bostutinib 400 mg daily concurrently with Gemcitabine

Drug: Gemcitabine, Bosutinib
Gemcitabine, 1000 mg/m2 on D1,8,15 over 30 mins standard infusion rate Bosutinib 400 mg, oral, once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the pancreas.
  • Complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). Positive microscopic margins are allowable.
  • No measurable disease.
  • ECOG performance status 0 - 1.
  • ≥ 18 years of age.
  • Ability to start adjuvant therapy within 8 weeks after pancreatic cancer surgery (but no sooner than 3 weeks).
  • CA 19-9 ≤ 2.5 times the upper limit of normal.
  • ANC (absolute neutrophil count) ≥ 1500/μL
  • Hemoglobin ≥ 9 gm/dL (may be transfused or may receive epoetin alfa to maintain this level)
  • Platelet count ≥ 100,000/μL
  • INR ≤ 1.5 (except those subjects who are receiving full-dose warfarin)
  • Total bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.5 times the upper limit of normal
  • Serum creatinine ≤ 2.0
  • Negative pregnancy test for women of childbearing potential (serum or urine beta-HCG).
  • All patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
  • Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards.
  • At least one paraffin block from patient's pancreatic cancer surgery must be available for analysis (does not necessarily need to be received by the start of study treatment).

Exclusion Criteria:

  • Any prior systemic or investigational therapy for pancreatic cancer.
  • Grossly positive surgical margins.
  • Any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula.
  • History of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications.
  • Serious active ongoing infection, including any requiring parenteral antibiotics.
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse.
  • Pregnancy (positive pregnancy test) or lactation.
  • Known central nervous system disease.
  • Inability to swallow pills/tolerate oral intake.
  • Inability to comply with study and/or follow-up procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025570

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Utah
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of California, San Francisco
University of Utah
Investigators
Principal Investigator: Andrew H. Ko, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01025570     History of Changes
Other Study ID Numbers: 09456, 10-00560
Study First Received: December 1, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
pancreas
pancreatic
bosutinib
SKI-606
gemcitabine
gemzar
Patients with resected pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 26, 2014