Metastatic Pancreatic Cancer
Conditions
Keywords
Stage IVB
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.
Interventions
DRUGGemcitabine, 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.
Sponsors
Sanofi
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer | 10 weeks | Data was not analyzed because original PI left institution before data analysis was completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine Overall and One Year Survival Rates | One year | Data was not analyzed because original PI left institution before data analysis was completed. |
| Toxicity Assessment | Every month | Data was not analyzed because original PI left institution before data analysis was completed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemzar, Taxotere, Xeloda Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
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. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 4 |
| Overall Study | Other | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Screen failure | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Gemzar, Taxotere, Xeloda |
|---|---|
| Age, Customized Between 30 and 39 years | 2 participants |
| Age, Customized Between 40 and 49 years | 4 participants |
| Age, Customized Between 50 and 59 years | 16 participants |
| Age, Customized Between 60 and 69 years | 20 participants |
| Age, Customized Between 70 and 79 years | 3 participants |
| Age, Customized Unknown | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 45 |
| serious Total, serious adverse events | 16 / 45 |
Outcome results
Primary
To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer
Data was not analyzed because original PI left institution before data analysis was completed.
Time frame: 10 weeks
Secondary
Determine Overall and One Year Survival Rates
Data was not analyzed because original PI left institution before data analysis was completed.
Time frame: One year
Secondary
Toxicity Assessment
Data was not analyzed because original PI left institution before data analysis was completed.
Time frame: Every month