Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Lenalidomide; Gemcitabine
Intervention description: 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 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.
Intervention MeSH terms: Gemcitabine; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic; Pancreatic Cancer; Lenalidomide; Revlimid; Gemcitabine

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.
    

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).