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Pancreatic CancerPhase 2NCT00766636

Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy

A Phase 2 study testing Gemcitabine, Radiation Therapy and Erlotinib in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary Objective: To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine, Radiation Therapy and Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Sep 2008to Nov 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.
  • 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.
  • Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to treatment
  • There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
  • 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
  • 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
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  • Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
  • 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.
  • Patients must sign a study-specific consent form, which is attached to this protocol.

Who cannot join

  • Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
  • Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • Known presence of central nervous system or brain metastases
  • Inability to comply with study and/or follow-up procedures
  • Patients < 18 years of age.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

Primary Objective:

To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.

Secondary Objectives:

  • To assess disease free survival
  • To assess overall survival
  • To assess patterns of local and distant failure
Read the detailed description

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.

Being tested
Gemcitabine, Radiation Therapy, Erlotinib, Surgery
Keywords
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
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called Gemzar

    Arm A:

    1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.

    Arm B:

    400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day.

  • Radiation TherapyRadiation

    Also called RT, Radiotherapy, External Beam Radiation Therapy, EBRT

    1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy.

  • ErlotinibDrug

    Also called Erlotinib Hydrochloride, OSI-774, Tarceva

    100 mg daily by mouth on days 1-42.

  • SurgeryProcedure or surgery

    Also called pancreaticoduodenectomy, resection

    Surgical removal of the pancreas and duodenum

Study groups in NCT00766636
Study groupRoleWhat they receive
Gemcitabine + Erlotinib Without RadiationExperimentalGemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Surgical removal of the pancreas and duodenum.
Receives: Drug: Gemcitabine; Drug: Erlotinib; Procedure: Surgery
Gemcitabine + Erlotinib With RadiationExperimentalGemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
Receives: Drug: Gemcitabine; Radiation: Radiation Therapy; Drug: Erlotinib; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.

    Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report

    Measured: Following resection performed at time of surgery, day 36 of treatment +/- 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2012

Why it stopped: Slow Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00766636
Sponsor's protocol ID
2008-0459
Status last verified
Aug 2015
First submitted
3 Oct 2008
Last updated
19 May 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Radiation Therapy and Erlotinib in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups. (time frame: Following resection performed at time of surgery, day 36 of treatment +/- 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00766636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.

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