Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

NCT00593008

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Adenocarcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
Official Title  ICMJE A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Adenocarcinoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 1, 2011)
5
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2008)
30
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00593008
Other Study ID Numbers  ICMJE 07-115
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eunice L. Kwak, MD, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Eunice Kwak, MD, PhDMassachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP