MDACC Study Summary 2004-0983

Study Summary
No. 2004-0983:.......Gastrointestinal......Christopher H. Crane......Radiation Oncology

Study Summary Title



Study Summary Number:	2004-0983

Study Title:	Phase II trial of induction cetuximab (IM-C225) gemcitabine and oxaliplatin, followed by radiotherapy with concurrent capecitabine, and cetuximab, followed by maintenance cetuximab and gemcitabine for patients with locally advanced pancreatic cancer

Physician

New Patient Referral



Name:	Christopher H. Crane	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Gastrointestinal	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patient will be seen on a weekly basis. Patient will been seen every 2 weeks during induction and maintenance phases during chemoradiation.

Treatment Agents:	Capecitabine Cetuximab Gemcitabine Oxaliplatin Radiation	Home Care:	All treatment must be given at MDACC.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if the drug cetuximab (C225, ErbituxTM) combined with chemotherapy (gemcitabine and oxaliplatin) followed by radiation therapy given with chemotherapy (capecitabine) and cetuximab will help to control pancreatic cancer. The safety of this combination treatment will also be studied.

Study Objectives / Outcomes

The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary endpoint is actuarial one-year survival.

The secondary objectives are:

- To evaluate the local tumor response in patients treated with the above regimen.

- To characterize the safety of the above regimen.

Study Status Information



Study Activation / Registration Date:	09/15/2005

IRB Review and Approval Date:	04/06/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	69

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment. Patients can have tumor originating in any part of the pancreas. Islet cell tumors are not eligible. Only patients with non- metastatic, unresectable disease (AJCC 2002 stage T4 NX M0) are eligible. CT findings of lung, liver, peritoneal metastasis are equivocal, are eligible. Patients who cannot undergo resection because of underlying medical problems are also eligible. Diagnosis of Pancreatic Adenocarcinoma by bile duce brushings are acceptable. Patients with regional nodal disease are eligible.

2) All patients must be staged with a physical exam, CXR, and contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or SM/ portal vein confluence. If a tumor does not meet this definition and is found to be unresectable at surgical exploration, then that tumor is considered unresectable.

3) Patients must be 18 years and older. There will be no upper age restriction

4) Karnofsky performance status greater than or equal to 70 are eligible.

5) Patients must either be not of child bearing potential or have a negative urine pregnancy test within 72 hours of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they have been postmenopausal for at least 12 months.

6) Women of childbearing potential must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent. Sexually active males must practice contraception during the study.

7) Bone marrow function: absolute neutrophil count (ANC) >1,500/ul. Platelets >100,000/ul.

8) Renal function: creatinine clearance >30 mL/min (calculated with Cockcroft-Gault equation).

9) Hepatic function: Total bilirubin less than 5mg/dL. If the patient required an endobiliary stent, the bilirubin level must have declined on consecutive measurements indicating adequate biliary decompression; alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.

10) Neurologic function: neuropathy (sensory) < CTC Grade 2.

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

Exclusion Criteria:

1) Patients with a history of prior metastatic cancer.

2) Patients must not have significant infection,i.e., requiring IV antibiotics, or other coexistent medical condition that would preclude protocol therapy.

3) Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with ejection fraction less than <30%.

4) Prior therapy which specifically and directly targets the EGFR pathway.

5) Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a monoclonal antibody.

6) Any prior history of radiotherapy to the abdomen.

7) History or evidence upon physical examination of CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)

8) Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5–fluorouracil.

9) Patients who have had an organ allograft.

10) Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) Coumadin is allowed.

11) Patients taking Sorivudine or Brivudine A must be off of these drugs for 4 weeks prior to starting capecitabine. Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary.

Links

Registration Number: NCT00338039
Study Information on Clinical Trials Registry (clinicaltrials.gov)