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A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas

Phase 2
18 Years
Not Enrolling
Metastatic Pancreatic Cancer

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Trial Information

A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas

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.

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

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).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment

Outcome Description:

The percentage of patients who were alive 6 months after beginning treatment

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jeffrey R Infante, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

June 2012

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic
  • Pancreatic Cancer
  • Lenalidomide
  • Revlimid
  • Gemcitabine
  • Carcinoma
  • Pancreatic Neoplasms



Florida Cancer Specialists Fort Myers, Florida  33901
Northeast Georgia Medical Center Gainesville, Georgia  30501
South Carolina Oncology Associates, PA Columbia, South Carolina  29210
Virginia Cancer Institute Richmond, Virginia  23230
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Oncology Hematology Care Cincinnati, Ohio  45242
Watson Clinic Center for Cancer Care and Research Lakeland, Florida  33805
Norton Cancer Institute Louisville, Kentucky  40207
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404