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

NCT01025570 | Terminated Phase 1 DMC

• 2 other identifiers: 0945610-00560
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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

Keywords

pancreas; pancreatic; bosutinib; SKI-606; gemcitabine; gemzar; Patients with resected pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer.

  8 weeks after the 6th patient is enrolled

• To estimate the median disease-free survival rate of patients with completely resected pancreatic cancer treated with this combination

  2 years after last patient is enrolled

Secondary Outcomes (2)

• To determine the overall survival rates of patients with completely resected pancreatic cancer when treated postoperatively with the combination of gemcitabine and bosutinib

  2 years after last patient is enrolled

• To estimate both disease-free and overall survival at one and two years of patients with completely resected pancreatic cancer treated with this combination

  2 years after last patient is enrolled

Study Arms (1)

Gem/Bos

EXPERIMENTAL

Gemcitabine 1000 mg/m2, D1,8,15 of each cycle Bostutinib 400 mg daily concurrently with Gemcitabine

Drug: Gemcitabine, Bosutinib

Interventions

Gemcitabine, Bosutinib DRUG

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

Gem/Bos

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Utah: collaborator

Study Sites (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; bosutinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Andrew H. Ko, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 3, 2009
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

US (2)