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

NCT ID: NCT01025570

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gem/Bos

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

Bostutinib 400 mg daily concurrently with Gemcitabine

Group Type: EXPERIMENTAL

Gemcitabine, Bosutinib

Intervention Type: DRUG

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

Interventions

Gemcitabine, Bosutinib

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew H. Ko, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

10-00560

Identifier Type: OTHER

Identifier Source: secondary_id

09456

Identifier Type: -

Identifier Source: org_study_id