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

NCT ID: NCT00996333

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2014-10-31

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.

Detailed 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.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Gemcitabine, Docetaxel, Capecitabine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Gemzar; Xeloda; Taxotere

Eligibility Criteria

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 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
• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L Fine, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAB8628

Identifier Type: -

Identifier Source: org_study_id