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Phase II Study of Erlotinib (Tarceva) Combined With Chemoradiation and Adjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase II Study of Erlotinib (Tarceva) Combined With Chemoradiation and Adjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer



- Determine the pharmacodynamic (inhibition of epidermal growth factor receptor [EGFR]
activation and signaling) effects of neoadjuvant erlotinib hydrochloride on tumor
tissue of patients with resectable stage I or II pancreatic adenocarcinoma.

- Determine, preliminarily, antitumor activity (progression-free survival) of adjuvant
erlotinib hydrochloride in combination with standard chemoradiotherapy comprising
capecitabine, gemcitabine hydrochloride, and radiotherapy after surgical resection in
these patients.


- Characterize the toxicity profile of adjuvant erlotinib hydrochloride in combination
with standard chemoradiotherapy in these patients.

- Determine the pharmacodynamic (inhibition of EGFR activation and signaling) effects of
erlotinib hydrochloride on normal tissue (skin and oral mucosa) of patients receiving
erlotinib hydrochloride as adjuvant therapy.

- Characterize the pharmacokinetics of erlotinib hydrochloride (assessing both total and
unbound levels) given in combination with capecitabine and evaluate the association of
common allelic variants in candidate genes (EGFR, TS, DPD, MTHFR, and ORM1) with drug
disposition and toxicity.

- Determine the relationships between pharmacodynamic effects and patient outcome.

- Assess the value of PET/CT scanning as a predictor of response to erlotinib
hydrochloride treatment in patients with pancreatic cancer.

- Evaluate the benefit of fusing PET/CT scans together with the radiation treatment
planning CT scan.

- Determine if the Active Breathing Coordinator (ABC) minimizes the effects of
respiratory motion during radiation treatment and results in better radiation coverage
of the tumor bed and adjacent lymph nodes.

OUTLINE: This is a randomized, placebo-controlled study.

- Neoadjuvant therapy: Patients are randomized to 1 of 2 neoadjuvant treatment arms.

- Arm I: Patients receive oral erlotinib hydrochloride once a day for 3-5 days.
Patients then proceed to surgery.

- Arm II: Patients receive oral placebo once a day for 3-5 days. Patients then
proceed to surgery.

- Surgery: Patients undergo surgical resection. Patients then proceed to adjuvant

- Adjuvant therapy: Patients receive oral capecitabine twice a day and oral erlotinib
hydrochloride once a day for 5½ weeks. Patients also undergo concurrent radiotherapy 5
days a week for 5½ weeks. Beginning 6 weeks later, patients receive gemcitabine
hydrochloride IV on days 1, 8, and 15 and oral erlotinib hydrochloride once daily on
days 1-28. Treatment with gemcitabine hydrochloride and erlotinib hydrochloride repeats
every 28 days for 4 courses.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of adenocarcinoma of the pancreas

- Stage I or II disease

- Previously untreated disease

- Scheduled to undergo surgical resection at The Johns Hopkins Hospital

- Candidate for postoperative adjuvant chemoradiation


- ECOG performance status 0-1

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- WBC ≥ 3,000/mm^3

- AST and ALT < 5 times upper limit of normal (ULN)

- Bilirubin < 2.0 mg/dL

- Creatinine < 2.0 mg/dL

- aPTT < 40 seconds

- PT < 2 seconds more than ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Patients with high glucose levels ( > 140 mg/dL) are eligible but may not undergo PET
scanning during the first part of the study

- No hypersensitivity to capecitabine, doxifluridine, or fluorouracil

- No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients
of this product

- No other coexisting malignancies or malignancies diagnosed within the last 5 years,
except basal cell carcinoma or cervical cancer in situ

- No ongoing or active infection

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No psychiatric illness or social situations that would limit compliance with study

- No other uncontrolled illness

- No gastrointestinal tract disease resulting in an inability to take oral medication

- No known AIDS

- No evidence of clinically active interstitial lung disease

- Patients with chronic stable radiographic changes who are asymptomatic are


- Recovered from previous oncologic or other major surgery

- No previous radiation to the abdomen

- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or
Hypericum perforatum (St John's wort)

- No concurrent antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Pharmacodynamics of neoadjuvant erlotinib

Safety Issue:


Principal Investigator

Joseph Herman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • Pancreatic Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410