Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)

Columbia University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pancreatic Cancer Stage III; Pancreatic Cancer Stage II

Treatments: Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel; Drug: Gemcitabine, capecitabine, docetaxel followed by radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01065870

AAAD6491

Details and patient eligibility

About

This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16 mutations.)
• Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
• No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
• Unresectable tumor. (this reflects those patients whose tumors abut, invade or surround a major vessel, either venous or arterial or both)
• No prior chemotherapy or radiation therapy.
• Ineligible for other high priority national or institutional studies.
• Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant, non-menopausal females.
• Must not have other underlying medical conditions that would make them ineligible for surgery, radiation therapy, or chemotherapy.
• Complete Blood Count and Complete Metabolic Profile:

Absolute Neutrophil Count > 1,500 μl White Blood Count > 3,000/μl Platelet count > 100,000/μl BUN < 1.5 x normal Creatinine < 1.5 normal Hemoglobin > 8.0 g/dl Serum Albumin > 3 mg/dl Total Bilirubin < 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase < 2.5 x ULN

• Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the nature of this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Group I

Experimental group

Description:

Patients with only venous involvement Treated with 6 cycles og GTX and then surgery

Treatment:

Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel

Group II

Experimental group

Description:

Patients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery

Treatment:

Drug: Gemcitabine, capecitabine, docetaxel followed by radiotherapy