Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
This study has been terminated.
Sponsor:
Massachusetts General Hospital
Collaborators:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Eunice L. Kwak, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00593008
First received: December 28, 2007
Last updated: December 1, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Adenocarcinoma |
Drug: Temsirolimus Drug: Gemcitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer |
Resource links provided by NLM:
Drug Information available for:
Sirolimus
Gemcitabine
Gemcitabine hydrochloride
Everolimus
Temsirolimus
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine whether order of administration of the drugs affects the above [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine the dosing regimen appropriate for Phase 2 studies of the combination [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To document objective response rate and progression-free survival in patients treated with this combination [ Time Frame: TBD ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Temsirolimus
Given intravenously every week of each 28-day cycle (days 1, 8, 15 and 22). Participants may continue to receive study treatment as long as their tumor is responding and they don't experience any serious side effects.
Drug: Gemcitabine
Given intravenously every other week of each 28-day cycle.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593008
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | Eunice Kwak, MD, PhD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Eunice L. Kwak, MD, PhD, Assistant in Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00593008 History of Changes |
| Other Study ID Numbers: | 07-115 |
| Study First Received: | December 28, 2007 |
| Last Updated: | December 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
metastatic pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine |
Sirolimus Everolimus Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013