Clinical trial · Interventional
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
NCT00593008CI-TRIAL-00005859terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
- timeFrame
- 2 years
- measure
- To determine whether order of administration of the drugs affects the above
- timeFrame
- 2 years
- measure
- To determine the dosing regimen appropriate for Phase 2 studies of the combination
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- To document objective response rate and progression-free survival in patients treated with this combination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.