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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996333
• Other study ID #: AAAB8628
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2009
• Last updated: February 12, 2013
• Start date: June 2003
• Est. completion date: December 2007

Study information

• Verified date: February 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 ß-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

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine response rate to the GTX regimen in patients with pancreatic cancer		10 weeks	Yes
Secondary	Determine overall and one year survival rates		One year	No
Secondary	Toxicity assessment		Every month	Yes