Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

Mass General Brigham

Status and phase

Terminated

Phase 1

Conditions

Pancreatic Adenocarcinoma

Treatments

Drug: Gemcitabine

Drug: Temsirolimus

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00593008

07-115

Details and patient eligibility

About

The purpose of this research study is to try to define the highest doses of temsirolimus and gemcitabine that can be used safely in combination to treat advanced pancreatic cancer. Gemcitabine is a standard chemotherapy used for the treatment of pancreatic cancer.

Full description

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 </= 2.5 x ULN
Total bilirubin </= 1.5 x ULN
Serum albumin >/= 2.5g/dL
Absolute neutrophil count >/= 1500/mm3; platelets >/= 100,000/mm3; hemoglobin >/= 9.0 g/dL
Serum creatinine </= 1.5 x ULN
Subjects with diabetes must have adequate glycemic control, with fasting serum glucose </= 1.5 x ULN
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