A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

NCT00336700 | Terminated Phase 2 Results DMC

• 1 other identifier: 06-016
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months.

Conditions

Pancreatic Cancer

Keywords

Pancreas; Cancer; Pancreatic

Outcome Measures

Primary Outcomes (3)

• Recurrence Free Survival (RFS)

  The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.

  Up to 60 months

• 1-year Recurrence Free Survival (RFS)

  Up to 60 months

• 2-year Recurrence Free Survival (RFS)

  Up to 60 months

Secondary Outcomes (3)

• Estimated 1&2 Year Overall Survival (OS)

  Up to 60 months

• Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)

  Up to 60 months

• KRAS Mutational Status

  Up to 60 months

Study Arms (1)

Gemcitabine and Erlotinib

EXPERIMENTAL

Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months

Drug: Gemcitabine; Drug: Erlotinib

Interventions

Gemcitabine DRUG

1500mg/m2 IV over 150 min IV q 2 weeks 4 months

Also known as: Gemzar

Gemcitabine and Erlotinib

Erlotinib DRUG

150 mg/d Daily, oral 12 months

Also known as: Tarceva

Gemcitabine and Erlotinib

Eligibility Criteria

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

You may qualify if:

• Patients with potentially resectable pancreatic cancer (including ampullary cancer), prior to or after surgery will be accrued to this study.
• Patients who sign consent prior to surgery must have appropriate diagnostic imaging and be evaluated by one of the surgical co-investigators as having resectable disease, and probable pancreatic adenocarcinoma.
• Patients, who sign consent after surgery, must have adenocarcinoma of the pancreas with negative surgical margins.
• Adjuvant therapy should start within 10 weeks of surgery
• Age 18 years or older
• ECOG performance status of 0 - 1 (see Appendix A)
• Ability to take oral medications without difficulty
• Adequate bone marrow function as evidenced by an absolute neutrophil content (ANC) \> 1500/mL and platelet count \> 100,000/mL
• Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance \> 50 ml/minute if above upper institutional limits (ULN)
• Adequate hepatic function as evidenced by ALT and total bilirubin within 2 times ULN.
• Provision of written informed consent.
• Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

You may not qualify if:

• Positive margins on post operative surgical specimen or evidence of metastatic disease (positive retroperitoneal margin is allowed)
• Biliary tree cancers are not allowed (Note: Ampullary cancer allowed).
• Known severe hypersensitivity to erlotinib or any of the excipients of these products
• Any prior treatment with radiation therapy or chemotherapy or vaccines for pancreatic cancer.
• Other coexisting malignancies or malignancies diagnosed within the last 3 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's Wort. Other agents which inhibit CYP3A4 may be used with caution (Appendix B)
• Treatment with a non-approved or investigational drug prior to treatment.
• Incomplete healing from previous oncologic or other major surgery.
• Pregnancy or breast feeding (women of childbearing potential).
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.

Sponsors & Collaborators

• Herbert J. Zeh, III MD, FACS: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UPMC Cancer Centers Network

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Gemcitabine; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; 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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Herbert Zeh, MD
• Organization: UPMC CancerCenter

zehxhx@upmc.edu

412-692-2852

Study Officials

• Herb Zeh, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 14, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 19, 2016
• Results First Posted: September 19, 2016

Record last verified: 2016-07

Locations

US (1)