A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer

NCT00882310 | Completed Phase 2 Results DMC

• 1 other identifier: AAAB4460
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pancreatic cancer, who have undergone complete surgical resection of their tumor. During the screening evaluation, subjects will have a physical exam and medical history taken by either the PI or a Co investigator. In addition, routine blood tests and radiological exams will be performed, to determine eligibility. Following enrollment, patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each cycle of treatment patients will have a physical examination, as well as routine blood work. The first scan will be done prior to initiation of treatment, and the next will be done at completion of chemotherapy. A short quality of life questionnaire will also be administered prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Gemzar; Taxotere; Xeloda; GTX

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)

  Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Data was not analyzed because original PI left institution before data analysis was completed.

  At days 4, 11, and follow-up.

Secondary Outcomes (2)

• Time to Death

  At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.

• Score on FACT-Hep (Version 4)

  Prior to starting treatment, after 3 months of treatment, and at the end of study visit.

Study Arms (1)

Gemcitabine, Docetaxel, Capecitabine GTX

EXPERIMENTAL

GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.

Drug: Gemcitabine; Drug: Docetaxel; Drug: Capecitabine

Interventions

Gemcitabine DRUG

Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV

Also known as: Gemzar

Gemcitabine, Docetaxel, Capecitabine GTX

Docetaxel DRUG

Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV

Also known as: Taxotere

Gemcitabine, Docetaxel, Capecitabine GTX

Capecitabine DRUG

Day 1-14: capecitabine at 1000 mg/m2/day divided into 2 doses given two times a day (BID) by mouth (PO) Maximum dose 2000mg/day divided into BID dosing

Also known as: Xeloda

Gemcitabine, Docetaxel, Capecitabine GTX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of pancreas that has been completely resected. Patients may be node negative or node-positive, but must have clean margins of resection.
• Ineligible for other high priority national or institutional studies.
• Time from surgical recovery greater than three weeks, but less than six weeks.
• All radiological evaluations (which must include either CT scans of the chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be performed within 4 weeks prior to the start of study therapy.
• 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.
• 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 6 months after completion of treatment. They must understand the risks of infertility possibly associated with adjuvant treatment.
• Clinical Parameters:
• Age ≥ 18 to ≤ 75 years old
• Performance status 0-2 (ECOG)
• Peripheral Neuropathy must be \< grade 1
• Able to tolerate oral medications
• Absolute Neutrophil Count \> 1,500 ul
• White Blood Count \> 3,000/ul
• Platelet count \> 100,000/ul
• BUN \< 1.5 x ULN

You may not qualify if:

• Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
• Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of any site in the body.
• Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
• Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
• Any prior investigational agent/therapy or any investigational agent/therapy while on protocol.
• Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drug formulated with polysorbate 80 will be excluded.

Sponsors & Collaborators

• Columbia University: lead

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, MD
• Organization: Columbia University

po2178@cumc.columbia.edu

212-305-0592

Study Officials

• Paul E Oberstein, 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: March 23, 2009
• First Posted: April 16, 2009
• Study Start: September 1, 2006
• 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