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Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer Stage II, Pancreatic Cancer Stage III

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Trial Information

Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

William Sherman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAD6491

NCT ID:

NCT01065870

Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer Stage II
  • Pancreatic Cancer Stage III
  • Pancreatic Neoplasms

Name

Location

Columbia University Medical CenterNew York, New York  10032