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An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer

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Trial Information

An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma


PRIMARY OBJECTIVES:

I. To describe the toxicity profile of cetuximab and bevacizumab when combined with
gemcitabine, before and after capecitabine plus radiation and during capecitabine plus
radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting.

II. To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in
patients with resected pancreatic cancer.

III. To obtain tissue specimens from resections of patients enrolled on study for
correlative studies and further evaluations.

SECONDARY OBJECTIVES:

I. To evaluate disease-free and overall survival for patients receiving either cetuximab or
bevacizumab in combination with gemcitabine before and after capecitabine plus radiation.

II. To assess the safety profile for patients receiving either capecitabine plus cetuximab
plus radiation, or capecitabine plus bevacizumab plus radiation.

III. To correlate changes in serum amphiregulin and TGF alpha to survival, DFS and rash for
patients receiving cetuximab.

IV. To determine the 2-year survival rate for patients receiving either cetuximab plus
gemcitabine before and after capecitabine plus cetuximab plus radiation, or bevacizumab plus
gemcitabine before and after capecitabine plus bevacizumab plus radiation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1
of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks
1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3,
13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks
5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and
continuing for approximately 5½ weeks (25 fractions).

Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9,
11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and
capecitabine and undergo radiotherapy as in arm I.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed evidence of pancreatic
carcinoma

- Patients must have had all gross disease resected (R0 or R1 resection)

- Patients undergoing an R2 resection are not eligible

- Patients must have had no prior chemotherapy or radiation therapy for pancreatic
cancer and must have had no prior EGFR/VEGF inhibition

- Patient must have ECOG performance status of 0-2

- Leukocytes >= 3,000/μL

- ANC >= 1,500/μL

- Platelets >= 100,000/μL

- Total bilirubin Within normal institutional limits

- AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

- Creatinine clearance >= 60 mL/min for patients with creatinine levels above
institutional normal

- Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration
(may be up to 10 weeks post-surgery prior to start of study therapy)

- Women of childbearing potential and sexually active males are strongly advised to use
an accepted and effective method of contraception prior to study entry

- Women must not be pregnant or breast-feeding; all agents used in this study as well
as radiation therapy to the abdomen have the potential for teratogenic or
abortifacient effects; all females of childbearing potential must have a blood test
or urine study within 2 weeks prior to registration to rule out pregnancy

- Patients must not be receiving any other investigational agents

- Patients with known metastases are not eligible

- Patients with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to cetuximab, bevacizumab or other agents used in
the study are not eligible

- Patients with wounds that have not fully healed are not eligible

- Patients must not have cardiac arrhythmia

- Patients must have no known HIV infection

- Patients must not have any of the following: acinar cell carcinoma, neuroendocrine
carcinoma, cystadenocarcinoma, carcinosarcoma

- Patients with psychiatric or addictive disorders or other conditions that, in the
opinion of the investigator, would preclude them from meeting the study requirements
are not eligible

- Patients requiring full dose anticoagulation are not eligible

- Patients with a history of transient ischemic attack (TIA) or cerebrovascular
accident (CVA) are not eligible

- Patients with a history of the following within twelve months of study entry are not
eligible:

- Arterial thrombembolic events

- Unstable angina

- Myocardial infarction

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicities graded according to the CTCAE version 3.0

Outcome Description:

Evaluated separately in each treatment arm.

Outcome Time Frame:

Up to 23 weeks

Safety Issue:

Yes

Principal Investigator

Jordan Berlin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02969

NCT ID:

NCT00305877

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Eastern Cooperative Oncology GroupBoston, Massachusetts  02215