Pancreatic AdenocarcinomaPhase 1NCT00593008
Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
A Phase 1 study testing Temsirolimus and Gemcitabine in people with Pancreatic Adenocarcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Temsirolimus and Gemcitabine
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
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.
Read the 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.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Temsirolimus, Gemcitabine
- Keywords
- metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
Measured: 2 years
To determine whether order of administration of the drugs affects the above
Measured: 2 years
To determine the dosing regimen appropriate for Phase 2 studies of the combination
Measured: 2 years
Secondary outcomes (1)
To document objective response rate and progression-free survival in patients treated with this combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Dana-Farber Cancer Institute, Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Eunice L. Kwak, MD, PhD, Massachusetts General Hospital
- Investigators
- Eunice Kwak, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593008
- Sponsor's protocol ID
- 07-115
- Status last verified
- Dec 2011
- First submitted
- 28 Dec 2007
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00593008
- Acronym / sponsor ID
- 07-115
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- metastatic pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Dana-Farber Cancer Institute, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemsirolimusGiven 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 | – |
| GemcitabineGiven intravenously every other week of each 28-day cycle. | Drug | – |
Primary outcome
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus
Time frame: 2 years
To determine whether order of administration of the drugs affects the above
Time frame: 2 years
To determine the dosing regimen appropriate for Phase 2 studies of the combination
Time frame: 2 years
1 secondary outcome
To document objective response rate and progression-free survival in patients treated with this combination
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunice Kwak, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Temsirolimus and Gemcitabine in people with Pancreatic Adenocarcinoma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the dose-limiting toxicities and maximal tolerated doses of gemcitabine combined with temsirolimus (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011.