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A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas


The Study Drugs:

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells
to die.

Erlotinib is designed to block the activity of a protein found on the surface of many tumor
cells that may control tumor growth and survival. This may stop tumors from growing.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study.
You will have "screening tests" to help the doctor decide if you are eligible to take part
in this study. The following tests and procedures will be performed:

- You will have a complete physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests. This routine blood draw
will include a pregnancy test for women who are able to have children. To take part in
this study, the pregnancy test must be negative.

- You will be asked about any side effects you may have experienced.

- Urine will be collected for routine tests.

- You will have chest x-rays and computed tomography (CT) scans of the abdomen to check
the status of the disease.

The study doctor will discuss the screening test results with you. If the screening tests
show that you are not eligible to take part in the study, you will not be enrolled. Other
treatment options will be discussed with you.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to receive either chemotherapy without radiation (Group A) or
chemotherapy with radiation (Group B). You will have an equal chance of being in either
group.

Pre-Surgery Study Drug Administration:

- If you are in Group A, you will receive gemcitabine over about 90 minutes 1 time each
week (Days 1, 8, 15, 22, 29, 36 [+/- 2 Days]. You will take erlotinib by mouth, with
water, 1 hour before eating or 2 hours after eating 1 time daily on Days 1-42.

- If you are in Group B, you will receive gemcitabine over about 40 minutes 1 time each
week (Days 1, 8, 15, 22, 29, 36, [+/- 2 Days]). You will take erlotinib by mouth, with
water, 1 hour before eating or 2 hours after eating 1 time daily on Days 1-42. You
will also receive radiation therapy 1 time each day for 5 days in a row (Monday through
Friday) for 5 1/2 weeks starting on Day 1. You will sign a separate consent form for
the radiation therapy. If any days of radiation therapy are missed, you will make up
the missed day(s) at the end of therapy so you receive the full amount of radiation
therapy.

Post-Surgery Study Drug Administration:

For all participants, starting within 12 weeks after the surgery, you will receive
gemcitabine over 100 minutes on Days 1, 8, and 15 [+/- 2 Days]) of each 4 weeks cycle. You
will also take erlotinib by mouth with water 1 hour before eating or 2 hours after eating 1
time daily for 4 weeks.

You may be able to receive your postoperative therapy closer to home by an outside cancer
doctor. This will be up to the treating cancer doctor at M. D. Anderson. A research nurse
will contact you at least every other week by telephone. Participants who need radiation
treatment will only be allowed to receive radiation treatment at M. D. Anderson Cancer
Center.

Surgery:

All participants will have chest x-rays and CT scans performed approximately 4 weeks after
the last dose of the study drug combination to check the status of the disease. If the
disease has not gotten worse, and the study doctor thinks it is in your best interest, you
will be scheduled to have surgery to remove the pancreas and duodenum. You will sign a
separate consent form for the surgery.

If you are not found to be eligible for surgery, your participation on this study end at
this time.

Length of Study:

You will be taken off study early if the disease gets worse, you experience intolerable side
effects, or the study doctor thinks it is no longer in your best interest to continue to
receive the study drug. You will remain on the study for approximately 10 months.

Follow-Up Visit:

After your participation on this study is complete, you will have a chest x-ray and a CT
scan every 4 months for 2 years.

This is an investigational study. Gemcitabine and Erlotinib are both FDA and commercially
available, but their use together with radiation therapy is investigational.

Up to 190 patients will take part in the study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate
process is required prior to treatment. Islet cell tumors are not eligible.

2. Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only
potentially resectable patients are eligible. Potentially resectable defined as: a)
no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac
axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV
confluence. Visceral angiography is optional. Laparoscopic staging is not part of the
pretreatment evaluation for this study. Laparoscopy may be performed prior to planned
laparotomy at surgeon's discretion. Staging needs to be done within 28 days of
enrollment.

3. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound
(US), CT scan, or laparotomy prior to treatment

4. There will be no upper age restriction; patients with Karnofsky performance status
greater than 70 are eligible.

5. Adequate renal, and bone marrow function: • Leukocytes >= 3,000/uL • Absolute
neutrophil count >= 1,500/uL • Platelets >= 100,000/Ul • Serum creatinine <= 2.0
mg/dL

6. Hepatic function (endoscopic or percutaneous drainage as needed) • Total bilirubin <
= 2 X institutional upper limits of normal (ULN) • AST (SGOT)/ALT (SGPT) <= 5 X
institutional ULN

7. Patients must have no fever or evidence of infection or other coexisting medical
condition that would preclude protocol therapy.

8. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this
study; women of childbearing potential (defined as those who have not undergone a
hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
must agree to practice adequate contraception and to refrain from breast feeding, as
specified in the informed consent.

9. Patients must sign a study-specific consent form, which is attached to this protocol.

Exclusion Criteria:

1. Tumors in the body or tail of the pancreas (to the left of the portal -SMV
confluence) are not eligible.

2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive
heart failure

3. Known presence of central nervous system or brain metastases

4. Inability to comply with study and/or follow-up procedures

5. Patients < 18 years of age.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Difference in positive margin resection (R1) rate in patients undergo surgery between the two treatment groups

Outcome Time Frame:

Analysis at surgery performed 6-8 weeks preoperative therapy

Safety Issue:

No

Principal Investigator

Jason B. Fleming, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0459

NCT ID:

NCT00766636

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Adenocarcinoma of the pancreatic head
  • Pancreaticoduodenectomy
  • Preoperative chemotherapy
  • Chemoradiation
  • Resectable pancreatic cancer
  • Surgical removal of the pancreas and duodenum
  • External-beam radiation therapy
  • EBRT
  • Gemcitabine
  • Erlotinib
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030