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

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: Lenalidomide; Drug: Gemcitabine

• Registration Number: NCT00837031
• Lead Sponsor: SCRI Development Innovations, LLC

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Primary Completion: 2010-04
• Study Completion: 2012-06
• Status Verified: 2013-02
• Results First Submitted: 2013-02-08
• Results First Submitted QC: 2013-02-08
• Last Update Submitted: 2013-02-08
• Results First Posted: 2013-03-13
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Lenalidomide	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.
Intervention	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment	6 months	The percentage of patients who were alive 6 months after beginning treatment

Secondary Outcome Measures

Name	Time	Method
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	18 months	The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	18 months	Length of time, in months, that patients were alive from their first date of protocol treatment until death

Trial Locations

Locations (9)

Chattanooga Oncology Hematology Associates; 🇺🇸 Chattanooga, Tennessee, United States

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

South Carolina Oncology Associates, PA; 🇺🇸 Columbia, South Carolina, United States

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States

Watson Clinic Center for Cancer Care and Research; 🇺🇸 Lakeland, Florida, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

Virginia Cancer Institute; 🇺🇸 Richmond, Virginia, United States