Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
This study has been completed.
Information provided by (Responsible Party):
First received: October 14, 2009
Last updated: June 22, 2016
Last verified: June 2016
This study is designed to determine whether an investigational drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) 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.
Metastatic Pancreatic Cancer
Drug: Gemcitabine, Docetaxel, Capecitabine
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2014 (Final data collection date for primary outcome measure)
Experimental: Gemzar, Taxotere, Xeloda
Gemcitabine, Docetaxel, Capecitabine:
Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Drug: Gemcitabine, Docetaxel, Capecitabine
1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.
This Phase II multicenter study is designed to determine the response rate to a biochemically synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic pancreatic cancer. It will further determine the overall and one year survival rates, the diseasefree interval, and the toxicities for this regimen in patients with metastatic pancreatic cancer.
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed adenocarcinoma of pancreas metastatic to liver and/or lungs or peritoneal surface. (a.k.a. Stage IV B).
- No prior chemotherapy with Gemzar, Xeloda and Taxotere.
- Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.
The following lesions conventionally are not considered measurable:
- CNS lesions
- Blastic or lytic bone lesions (which should be documented and followed)
- Radiated lesions unless progression after RT is documented
- Ineligible for other high priority national or institutional studies
Prior radiation and surgery allowed:
- > 3 weeks since surgery
- > 4 weeks since RT
- Non pregnant females who are not breast feeding with a negative serum or urine 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.
- Life expectancy > 2 months
- Age 18 - 70 years old
- Performance status 0-2 (ECOG)
- Peripheral Neuropathy must be < grade 1
- Able to tolerate oral medications
Required initial laboratory data:
- 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 < 2.0 mg/dl
- SGOT, SGPT, Alkaline Phosphatase SGOT and SGPT may be up to 3.0 x ULN if Alk Phos < 2.0 x ULN; or Alk Phos may be up to 3.0 x ULN if SGOT and SGPT are < 2.0 x ULN
- 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.
- The patient has not had a prior malignancy in last 5 years other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with brain metastases are excluded.
- Patients known to have HIV will be excluded.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996333
|Columbia University Medical Center
|New York, New York, United States, 10032 |
||Robert L Fine, MD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 14, 2009
|Results First Received:
||April 27, 2016
||June 22, 2016
||United States: Institutional Review Board
|Individual Participant Data
|Plan to Share IPD:
Keywords provided by Columbia University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs