Study for Inoperable Non-Metastatic Pancreatic CA (Stage IVA) With Neoadjuvant GTX, and Radiation With Gemzar
Phase II Study for Inoperable Non-Metastatic Pancreatic Cancer (Stage IVA) With Neoadjuvant Gemzar, Taxotere and Xeloda (GTX), and Radiation With Gemzar
2 other identifiers
interventional
32
1 country
1
Brief Summary
The purpose of this study is to determine whether an experimental drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) when followed by radiation therapy plus low-dose Gemzar, is safe and effective in treating advanced pancreatic cancer and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
June 22, 2016
CompletedJune 22, 2016
May 1, 2016
9.3 years
March 23, 2009
April 19, 2016
May 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Conversion Rate of Inoperable to Operable
Data was not analyzed because original PI left institution before data analysis was completed.
10 weeks
Study Arms (1)
GTX and Radiation Therapy with Gemzar
EXPERIMENTALChemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine: A cycle of chemotherapy is made up of 21 days. During each cycle patients will take Xeloda® twice a day for 14 days followed by a rest period of 7 days. On day 4 and 11 (+/- 2 days) of each 21-day cycle patients will also receive Gemzar and Taxotere. Weekly Radiation Therapy with Low-Dose Gemzar Chemotherapy: After completing a total of 3 cycles of GTX chemotherapy each patient will receive 5 weeks of standard radiation therapy in combination with low-dose Gemzar chemotherapy.
Interventions
Day 1-14: Capecitabine 1500 mg/m2/day (+/- 2days) Day 4 and 11: Gemcitabine 750 mg/m2/day (+/- 2days) Day 4 and 11: Docetaxel 30 mg/m2/day (+/- 2 days) Two week treatment regimen is followed by one week off, repeated for a total of 3 cycles
Starting on week 12 +/- 5 days radiation therapy will be given in the standard manner over 5 weeks with daily radiation fractions Monday through Friday. Once a week gemcitabine will be given IV over 30 minutes at 250-300 mg/m2
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of pancreas localized to the pancreas, small bowel, stomach and/or encasing the superior mesenteric artery, vein or portal vein. (a.k.a. Stage IV A).
- No prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
- Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.
- Ineligible for other high priority national or institutional studies
- Whipple surgery not allowed. Prior surgery is allowed as long as it was not pancreatic resection (i.e. Whipple surgery) and the time from surgical recovery is greater than three weeks.
- Non pregnant females who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
- Clinical Parameters
- Life expectancy \> 2 months.
- Age 18 to 70 years old
- Performance status 0-2 (ECOG). (See Appendix IV)
- Peripheral Neuropathy must be \< grade 1
- Able to tolerate oral medications
- Absolute Neutrophil Count \> 1,500 μl
- White Blood Count \> 3,000/μl
- Platelet count \> 100,000/μl
- +6 more criteria
You may not qualify if:
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
- 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 experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
- Prior malignancies in last 5 years other than: curatively treated carcinoma in-situ of the cervix, non-melanoma skin cancer, prostate or DCIS (ductal carcinoma in-situ) previously treated successfully (cancer free)
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients known to have HIV will be excluded.
- Patients cannot have received any prior investigational agent/therapy, nor will they be allowed any investigational agent/therapy while on protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (1)
Sherman WH, Hecht E, Leung D, Chu K. Predictors of Response and Survival in Locally Advanced Adenocarcinoma of the Pancreas Following Neoadjuvant GTX with or Without Radiation Therapy. Oncologist. 2018 Jan;23(1):4-e10. doi: 10.1634/theoncologist.2017-0208. Epub 2017 Dec 6.
PMID: 29212734DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Fine, MD
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Robert L Fine, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 25, 2009
Study Start
June 1, 2005
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
June 22, 2016
Results First Posted
June 22, 2016
Record last verified: 2016-05