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Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Adenocarcinoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Temsirolimus
Gemcitabine
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring metastatic pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
To determine whether order of administration of the drugs affects the above
To determine the dosing regimen appropriate for Phase 2 studies of the combination

Secondary Outcome Measures

To document objective response rate and progression-free survival in patients treated with this combination

Full Information

First Posted
December 28, 2007
Last Updated
December 1, 2011
Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00593008
Brief Title
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
Official Title
A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
metastatic pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Temsirolimus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Given intravenously every other week of each 28-day cycle.
Primary Outcome Measure Information:
Title
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
Time Frame
2 years
Title
To determine whether order of administration of the drugs affects the above
Time Frame
2 years
Title
To determine the dosing regimen appropriate for Phase 2 studies of the combination
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To document objective response rate and progression-free survival in patients treated with this combination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunice Kwak, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

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