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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Sanofi
• Treatments: Capecitabine; Docetaxel; Gemcitabine

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.