Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

This study has been terminated.
Sponsor:
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
  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:


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:
    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.
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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pancreatic Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Everolimus
Gemcitabine
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on November 20, 2014