Clinical trial NCT00996333: Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Official title: Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Keywords: Stage IVB
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2009-10-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer
timeFrame: 10 weeks
Secondary outcomes:
measure: Determine Overall and One Year Survival Rates
timeFrame: One year
measure: Toxicity Assessment
timeFrame: Every month
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Robert L Fine, MD
role: PRINCIPAL_INVESTIGATOR
References: