Lenalidomide With Gemcitabine In Treatment Of Untreated Advanced Carcinoma Of The Pancreas

Study Overview

Lenalidomide With Gemcitabine in Treatment of 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.

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.

Metastatic Pancreatic Cancer

DRUG: Lenalidomide
DRUG: Gemcitabine

SCRI GI 106

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-02-04	Results First Submitted 2013-02-08	Last Update Submitted that met QC Criteria 2013-02-08
First Submitted that Met QC Criteria 2009-02-04	Results First Submitted that Met QC Criteria 2013-02-08	Last Update Posted (ESTIMATED) 2013-03-13
First Posted (ESTIMATED) 2009-02-05	Results First Posted 2013-03-13	Last Verified 2013-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intervention 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	DRUG: Lenalidomide 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 pati DRUG: Gemcitabine Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Intervention

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

DRUG: Lenalidomide

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 pati

DRUG: Gemcitabine

Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.

Primary Outcome Measures	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures	Measure Description	Time Frame
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	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	18 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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. 9. 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. 10. All study participants must be registered into the mandatory RevAssist® program, and must be willing and able to comply with the requirements of RevAssist®.

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).
Palliative radiation therapy within 14 days of the start of study. The radiation therapy may not be to the only site of measurable disease. 6. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement). 7. Neuropathy of ≥ grade 2. 8. Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Celgene Corporation

Investigators

STUDY_CHAIR: Jeffrey R Infante, M.D., SCRI Development Innovations, LLC

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record