Metastatic Pancreatic CancerPhase 2NCT00837031
Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas
A Phase 2 study testing Lenalidomide and Gemcitabine in people with Metastatic Pancreatic Cancer, run by SCRI Development Innovations, LLC at 9 sites in United States.
Trial summary
To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Lenalidomide and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Understand and voluntarily sign the informed consent form.
- Patients >=18 years of age at the time of signing the informed consent form.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Histological or cytological documentation of adenocarcinoma of the pancreas, with metastases not amenable to curative surgery or definitive radiation. Patients with locally advanced disease are not eligible.
- Radiographic or clinical evidence of measurable advanced metastatic pancreatic carcinoma. Patients must have measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions.
- Previous gemcitabine or 5-fluorouracil (5-FU) with radiation therapy as adjuvant therapy is permitted. Extended use of gemcitabine or 5-FU after completion of adjuvant radiation therapy is not permitted. No prior gemcitabine for metastatic disease or for primary treatment of locally advanced disease is allowed.
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- ECOG performance status of <=2 at study entry.
- Laboratory test results within these ranges:
- Absolute neutrophil count (ANC) ≥1,500 cells/mm3 (1.5 x 109/L)
- Platelet count ≥100,000 cells/ mm3 (100 x 109/L)
- Serum creatinine <=2.5 mg/dL
- Total bilirubin <=2.0 mg/dL
- AST (SGOT) and ALT (SGPT) <=3.0 x ULN or <=5 x ULN if hepatic metastases are present.
- Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast, or localized prostate cancer with PSA <1.0 ng/mL), unless the patient has been free of disease for >=3 years.
- All study participants must be registered into the mandatory RevAssist® program, and must be willing and able to comply with the requirements of RevAssist®.
Who cannot join
- Prior use of systemic therapy for the treatment of adenocarcinoma of the pancreas, with the exception of 5-fluorouracil or gemcitabine as a radiosensitizer in the adjuvant setting.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
- Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Surgery or radiation therapy within 14 days of study enrollment as outlined below.
- Surgery within 14 days of the start of study (patients must have recovered from effects of surgery; 7 days may be considered for minor procedures).
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- Palliative radiation therapy within 14 days of the start of study. The radiation therapy may not be to the only site of measurable disease.
- Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
- Neuropathy of ≥ grade 2.
- Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805
Norton Cancer Institute
Louisville, Kentucky, 40207
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Virginia Cancer Institute
Richmond, Virginia, 23235
About this study
Official title: A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas
To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer.
Read the detailed description
Because the activity of lenalidomide addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - lenalidomide is being evaluated as part of induction chemotherapy regimens for solid tumors. This phase II study in previously untreated metastatic pancreatic cancer is designed to establish and test the appropriate lenalidomide dose and regimen in combination with gemcitabine.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Lenalidomide, Gemcitabine
- Keywords
- Pancreatic, Pancreatic Cancer, Lenalidomide, Revlimid, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
The starting dose of lenalidomide for the lead-in portion will be 25 mg orally daily on Days 1-21, followed by a 7-day rest period (28-day cycle). If the 25-mg dose of lenalidomide is found to be intolerable or unsafe (i.e., if more than one of the 6 patients experience a DLT), then the dose will be reduced to 20 mg orally daily, and 6 additional patients will be treated. All patients will receive lenalidomide at the confirmed tolerable dose (either 25 mg or 20 mg given orally daily on Days 1-21 of a 28-day cycle) until disease progression. If the 20-mg daily dose is found to be intolerable or unsafe, enrollment will be put on hold.
GemcitabineDrug
Also called Gemzar
Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15).
After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred. Receives: Drug: Lenalidomide; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment
The percentage of patients who were alive 6 months after beginning treatment
Measured: 6 months
Secondary outcomes (2)
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Measured: 18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Length of time, in months, that patients were alive from their first date of protocol treatment until death
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Infante, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837031
- Sponsor's protocol ID
- SCRI GI 106
- Status last verified
- Feb 2013
- First submitted
- 4 Feb 2009
- Last updated
- 13 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT00837031
- Acronym / sponsor ID
- SCRI GI 106
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Pancreatic, Pancreatic Cancer, Lenalidomide, Revlimid, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 13 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer.
Detailed description
Because the activity of lenalidomide addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - lenalidomide is being evaluated as part of induction chemotherapy regimens for solid tumors. This phase II study in previously untreated metastatic pancreatic cancer is designed to establish and test the appropriate lenalidomide dose and regimen in combination with gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Lenalidomide, Drug: GemcitabineThe study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Understand and voluntarily sign the informed consent form.
- Patients >=18 years of age at the time of signing the informed consent form.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Histological or cytological documentation of adenocarcinoma of the pancreas, with metastases not amenable to curative surgery or definitive radiation. Patients with locally advanced disease are not eligible.
- Radiographic or clinical evidence of measurable advanced metastatic pancreatic carcinoma. Patients must have measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions.
Key exclusion criteria (10 listed)
- Prior use of systemic therapy for the treatment of adenocarcinoma of the pancreas, with the exception of 5-fluorouracil or gemcitabine as a radiosensitizer in the adjuvant setting.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
- Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Surgery or radiation therapy within 14 days of study enrollment as outlined below.
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 |
|---|---|---|
| LenalidomideAlso: RevlimidThe starting dose of lenalidomide for the lead-in portion will be 25 mg orally daily on Days 1-21, followed by a 7-day rest period (28-day cycle). If the 25-mg dose of lenalidomide is found to be intolerable or unsafe (i.e., if more than one of the 6 patients experience a DLT), then the dose will be reduced to 20 mg orally daily, and 6 additional patients will be treated. All patients will receive lenalidomide at the confirmed tolerable dose (either 25 mg or 20 mg given orally daily on Days 1-21 of a 28-day cycle) until disease progression. If the 20-mg daily dose is found to be intolerable or unsafe, enrollment will be put on hold. | Drug | Intervention |
| GemcitabineAlso: GemzarGemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle. | Drug | Intervention |
Primary outcome
Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment
Time frame: 6 months
The percentage of patients who were alive 6 months after beginning treatment
2 secondary outcomes
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Time frame: 18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey R Infante, M.D. study chair
SCRI Development Innovations, LLC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide and Gemcitabine in people with Metastatic Pancreatic Cancer, run by SCRI Development Innovations, LLC at 9 sites 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 15 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: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment (time frame: 6 months). 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 13 Mar 2013.