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Phase 3
18 Years
Open (Enrolling)
Adenocarcinoma of the Pancreas, Stage I Pancreatic Cancer, Stage II Pancreatic Cancer

Thank you

Trial Information



I. To determine whether the addition of erlotinib hydrochloride to adjuvant chemotherapy
comprising gemcitabine hydrochloride improves survival as compared to gemcitabine
hydrochloride alone following R0 or R1 resection in patients with pancreatic adenocarcinoma.

II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following
adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival of patients
who have no evidence of progressive disease after 5 courses of gemcitabine
hydrochloride-based chemotherapy.


I. To evaluate the disease-free survival of patients who are disease-free after 5 courses of
adjuvant gemcitabine hydrochloride-based chemotherapy followed by fluoropyrimidine-based

II. To evaluate the disease-free survival of patients treated with adjuvant gemcitabine
hydrochloride-based chemotherapy with vs without erlotinib hydrochloride.

III. To evaluate the disease-free and overall survival of patients stratified by wild-type
and K-Ras status treated with adjuvant gemcitabine hydrochloride-based chemotherapy with vs
without erlotinib hydrochloride.

IV. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based
chemotherapy with vs without erlotinib hydrochloride in these patients.

V. To evaluate adverse events associated with adjuvant gemcitabine hydrochloride-based
chemotherapy with vs without fluoropyrimidine-based chemoradiotherapy in patients who are
disease-free after adjuvant gemcitabine hydrochloride-based chemotherapy.

VI. To evaluate preoperative cross-sectional imaging of primary adenocarcinoma of the head
of the pancreas in order to determine the frequency with which objective criteria of
resectability are present.

VII. To determine the predictive roles of K-Ras mutations and epithelial to mesenchymal
transition phenotype in response to epidermal growth factor receptor (EGFR) tyrosine kinase
inhibition in early-stage pancreatic cancer.

VIII. To determine the frequency of EGFR-activated pathway and its influence on outcome.

IX. To determine the association between developmental molecular markers and outcome.

X. To determine the phenotype and genotype of tumors in patients with recurrence after

XI. To determine if low baseline fatigue, as measured by the FACIT-Fatigue, predicts

XII. To explore correlations between baseline fatigue, as measured by PROMIS, and survival.

OUTLINE: This is a multicenter study. Patients are stratified according to nodal status
(involved vs uninvolved), CA19-9 result (≤ 90 IU/L vs 91-180 IU/L), and surgical margins
(positive [R1] vs negative [R0]). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15.
Treatment repeats every 28 days for 5 courses in the absence of disease progression or
unacceptable toxicity.

ARM II: Patients receive gemcitabine hydrochloride as in arm I and oral erlotinib
hydrochloride once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the
absence of disease progression or unacceptable toxicity. Patients with no disease
progression after treatment in arm I or II are then stratified according to their first
randomization treatment arm (arm I vs arm II) and randomized to 1 of 2 additional treatment
arms (arm III or IV).

ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II.

ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II.
Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy
(3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week
for 5.5 weeks (28 fractions). During radiotherapy, patients receive either oral capecitabine
twice daily 5 days per week or fluorouracil IV continuously for 5.5 weeks or until
radiotherapy is completed.

After completion of study, patients are followed up periodically.

Inclusion Criteria:

- Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or
uncinate process

- Intraductal papillary mucinous neoplasm or invasive adenocarcinoma allowed

- No non-adenocarcinoma, adenosquamous carcinoma, islet cell (neuroendocrine)
tumor, cystadenoma, cystadenocarcinoma, carcinoid tumor, duodenal carcinoma,
distal bile duct tumor, or ampullary carcinoma

- Pathologic stage T1-3, N0-1, M0 disease according to American Joint Committee on
Cancer (AJCC) 6th edition

- Has undergone a potentially curative resection (i.e., removal of all gross tumor)
involving a classic (Whipple) or a pylorus preserving pancreaticoduodenectomy within
the past 21-56 days

- Operative report must contain a statement from the surgeon explicitly detailing
that a total gross excision of the primary tumor was achieved

- Pathology report must include documentation of margin status, size of the tumor,
and status of the 3 major surgical margins (bile duct, pancreatic parenchyma,
and retroperitoneal [uncinate])

- Post-resection serum CA19-9 =< 180 IU/L

- Tumor tissue block and peripheral blood samples must be submitted to the study's
central tumor bank for correlative studies

- No recurrent pancreatic cancer

- Zubrod performance status 0-1

- ANC >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)

- Serum total bilirubin =< 2 times upper limit of normal (ULN)

- Creatinine =< 2 times ULN

- SGOT =< 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Suitable to receive study radiotherapy, as documented by a radiation oncologist

- Active HIV infection allowed provided the CD4 count is >= 499/mm^3 and the viral load
is =< 50 copies/mL

- Total oral caloric intake >= 1,500 calories/day

- No significant nausea and vomiting

- None of the following severe active comorbidities that would preclude study therapy:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 3 months

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- No other invasive malignancies within the past 2 years except for nonmelanomatous
skin cancer or carcinoma in situ

- See Disease Characteristics

- No prior systemic chemotherapy for pancreatic cancer

- Prior chemotherapy for a different cancer allowed

- No prior total pancreatectomy, distal pancreatectomy, or central pancreatectomy

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiotherapy fields

- Concurrent highly active antiretroviral treatment (HAART) allowed

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival (first randomization)

Outcome Description:

Overall survival will be estimated by the Kaplan-Meier method. The distribution of overall survival estimates between the two arms for both primary endpoint questions will be compared using the log rank test. The Cox proportional hazard regression model will be used to analyze the effects of factors, in addition to treatment, that may be associated with overall survival.

Outcome Time Frame:

From the date of first randomization (gemcitabine vs. gemcitabine/erlotinib) to the date of death or last follow-up, assessed up to 11 years

Safety Issue:


Principal Investigator

Ross Abrams

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Therapy Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Stage I Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



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