Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)

NCT00996333 | Completed Phase 2 Results DMC

• 1 other identifier: AAAB8628
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Pancreatic Cancer

Keywords

Stage IVB

Outcome Measures

Primary Outcomes (1)

• To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer

  Data was not analyzed because original PI left institution before data analysis was completed.

  10 weeks

Secondary Outcomes (2)

• Determine Overall and One Year Survival Rates

  One year

• Toxicity Assessment

  Every month

Study Arms (1)

Gemzar, Taxotere, Xeloda

EXPERIMENTAL

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

Interventions

Gemcitabine, Docetaxel, Capecitabine DRUG

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.

Also known as: Gemzar, Xeloda, Taxotere

Gemzar, Taxotere, Xeloda

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Clinical Parameters:
• Life expectancy \> 2 months
• Age 18 - 70 years old

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.
• 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.

Sponsors & Collaborators

• Columbia University: lead
• Sanofi: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Docetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Paul Oberstein
• Organization: Columbia University

po2178@cumc.columbia.edu

212-305-0592

Study Officials

• Robert L Fine, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

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: October 14, 2009
• First Posted: October 16, 2009
• Study Start: June 1, 2003
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 25, 2016
• Results First Posted: June 22, 2016

Record last verified: 2016-06

Locations

US (1)