Temsirolimus in Combination With Gemcitabine in Previousl... | NCT00593008

Studies
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

NCT00593008

Sponsor

Massachusetts General Hospital

Status

Terminated

Last Update Posted

Dec 2, 2011Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Pancreatic Adenocarcinoma

Interventions

Temsirolimus
Gemcitabine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Dec 28, 2007

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2011

Last Update Posted Date

Dec 2, 2011Estimated

Name	Class
Brigham and Women's Hospital	OTHER
Dana-Farber Cancer Institute	OTHER
Wyeth is now a wholly owned subsidiary of Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Temsirolimus	Drug	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.
Gemcitabine	Drug	Given intravenously every other week of each 28-day cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides