NCT00593008

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 2, 2011

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

December 28, 2007

Last Update Submit

December 1, 2011

Conditions

Pancreatic Adenocarcinoma

Keywords

metastatic pancreatic cancer

Outcome Measures

Primary Outcomes (3)

  • To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus

    2 years

  • To determine whether order of administration of the drugs affects the above

    2 years

  • To determine the dosing regimen appropriate for Phase 2 studies of the combination

    2 years

Secondary Outcomes (1)

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

Interventions

TemsirolimusDRUG

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.

GemcitabineDRUG

Given intravenously every other week of each 28-day cycle.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

temsirolimusGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Eunice Kwak, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant in Medicine

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 14, 2008

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 2, 2011

Record last verified: 2011-12

Locations

US(1)