Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Stage II Pancreatic Cancer Stage III |
Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel Drug: Gemcitabine, capecitabine, docetaxel followed by radiotherapy |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group I
Patients with only venous involvement
|
Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel
6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off. Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner. Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment. Other Names:
|
|
Experimental: Group II
Patients with arterial involvement and may have venous involvement with tumor
|
Drug: Gemcitabine, capecitabine, docetaxel followed by radiotherapy
6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off. Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner. Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment. Radiotherapy should start 2 to 3 weeks after last planned dose of GTX. Gemcitabine at 750mg/M2 days 5, 12, 26, 33 along with capecitabine 1000 mg bid for 5 days darbepoetin 200ug, every 2 weeks if the hemoglobin is less than 10.5 gms/dl while undergoing radiotherapy. Pegfiligastrim 6mg at the end of week 2 if the WBC count is less than 2500 cells/cu mm. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Kyung Chu, RN | 212-305-9467 | kc2113@columbia.edu |
| Contact: Jessica Neufield | 2123051440 | jn2325@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Kyung Chu, RN 212-305-9467 kc2113@columbia.edu | |
| Contact: Jessica Neufield 2123051440 jn2325@columbia.edu | |
| Principal Investigator: William Sherman, MD | |
| Sub-Investigator: John Allendorf, MD | |
| Sub-Investigator: John Chabot, MD | |
| Sub-Investigator: Beth Schrope, MD | |
| Sub-Investigator: Peter Stevens, MD | |
| Sub-Investigator: Harold Frucht, MD | |
| Sub-Investigator: Shermian Woodhouse, MD | |
| Sub-Investigator: Inna Postolova, MD | |
| Sub-Investigator: Joan Prowda, MD | |
| Sub-Investigator: Wasif Saif, MD | |
| Principal Investigator: | William Sherman, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT01065870 History of Changes |
| Other Study ID Numbers: | AAAD6491 |
| Study First Received: | February 8, 2010 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine Fluorouracil Docetaxel Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 17, 2013