Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas

NCT ID: NCT00837031

Last Updated: 2013-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-06-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

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.

Gemcitabine

Intervention Type: DRUG

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

Interventions

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 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.

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Other Intervention Names

Revlimid; Gemzar

Eligibility Criteria

Inclusion Criteria

1. Understand and voluntarily sign the informed consent form.

2. Patients >=18 years of age at the time of signing the informed consent form.

3. Ability to adhere to the study visit schedule and other protocol requirements.

4. 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.

5. 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.

6. 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.

7. ECOG performance status of <=2 at study entry.

8. 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.

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®.

Exclusion Criteria

1. 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.

2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.

3. Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide).

4. 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.

5. 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).
• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey R Infante, M.D.

Role: STUDY_CHAIR

SCRI Development Innovations, LLC

Locations

Florida Cancer Specialists

Fort Myers, Florida, United States

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Countries

United States

Other Identifiers

SCRI GI 106

Identifier Type: -

Identifier Source: org_study_id