A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Adenocarcinoma
Trial Information
A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
- Because this is a study to determine the highest doses of temsirolimus and gemcitabine
that can be given safely together, groups of 3 subjects will be treated at gradually
increasing doses of the drugs. Each group of 3 subjects must complete 4 weeks of
treatment (1 cycle) before the following group of 3 subjects can start treatment at the
higher dose of drug.
- Temsirolimus will be given intravenously every week of the 28 day treatment cycle (days
1, 8, 15, 22). Gemcitabine will be given intravenously every other week of the
treatment cycle (days 1. 15).
- During the study, participants will have weekly clinic visits where the following tests
and procedures may be performed: Physical exam; vital signs; urine test; blood tests.
- A CT scan will be performed after every 2 cycles (8 weeks) to assess teh response of
the tumor to the study treatment.
Inclusion Criteria:
- Previously untreated metastatic pancreatic adenocarcinoma, histologically proven.
- Measurable disease by RECIST criteria
- ECOG Performance Status 0 or 1
- Male or female, 18 years of age or older
- Life expectancy of >/= 12 weeks
- AST and ALT
- Total bilirubin
- Serum albumin >/= 2.5g/dL
- Absolute neutrophil count >/= 1500/mm3; platelets >/= 100,000/mm3; hemoglobin >/= 9.0
g/dL
- Serum creatinine
- Subjects with diabetes must have adequate glycemic control, with fasting serum
glucose
- Female patients of childbearing age and male patients with partners of childbearing
age must agree to use adequate birth control measures during the course of the study
and for at least one month following withdrawal from the study
Exclusion Criteria:
- Previously treatment with gemcitabine or chemoradiation
- Diagnosis of a second malignancy within the last 3 years, except for adequately
treated basal cell carcinoma or squamous cell skin cancer
- Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2, atrial fibrillation, QTc
prolongation to > 450 msec for males and >470 msec for females
- Known immunodeficiency disorders or active infections requiring treatment
- Pregnancy or breastfeeding
- Known brain metastases, spinal cord compression, carcinomatous meningitis, or
leptomeningeal disease
- Prior radiation therapy or major surgery within 4 weeks of study entry
- Prior radiation therapy to > 25% of the bone marrow
- Subjects receiving other experimental or alternative therapies during the course of
the trial will be excluded
- History of prior hypersensitivity to polysorbate
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Eunice Kwak, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
07-115
NCT ID:
NCT00593008
Start Date:
October 2007
Completion Date:
October 2009
Related Keywords:
- Pancreatic Adenocarcinoma
- metastatic pancreatic cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
