Clinical trial NCT00336700: A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Official title: A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreas
Cancer
Pancreatic
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-06-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: PATIENT POPULATION Resected pancreatic cancer patients (R0 resection) within 10 weeks of surgery will be eligible, provided that they meet standard eligibility criteria.

STUDY DESIGN Phase II, open-label trial of erlotinib and gemcitabine. SAFETY PLAN Safety as assessed by CTCAE 3.0 STUDY TREATMENT Erlotinib 150 mg/day x 12 months. (oral) Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy.

Clinical Practice: Therapy will be administered as an outpatient. Primary Evaluations: Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Recurrence Free Survival (RFS)
timeFrame: Up to 60 months
measure: 1-year Recurrence Free Survival (RFS)
timeFrame: Up to 60 months
measure: 2-year Recurrence Free Survival (RFS)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Estimated 1&2 Year Overall Survival (OS)
timeFrame: Up to 60 months
measure: Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
timeFrame: Up to 60 months
measure: KRAS Mutational Status
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers Network
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Herb Zeh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: