Lenalidomide and Gemcitabine as First-line Treatment in Patients With Pancreatic Cancer

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to ascertain whether treatment with lenalidomide or lenalidomide in combination with gemcitabine induces modulation of immune effector functions and to characterize the nature of immune functions.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Liljefors
• Collaborators: Celgene Corporation; Karolinska Institutet; Karolinska University Hospital
• Treatments: Gemcitabine; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.

• ECOG performance status of 0 or 1, see Appendix 1.

• Life expectancy > 12 weeks.

• Must understand and voluntarily sign an informed consent form.

• Age > 18 years at the time of signing informed consent form.

• Must be able to adhere to the study visit schedule and other protocol requirements.

• Female subjects of childbearing potential† must:

• Understand that the study medication is expected to have a teratogenic risk

• Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea

• Male subjects must:

• Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.

• Agree not to donate semen during study drug therapy and for one week after end of study drug therapy

Exclusion Criteria:

• Prior use of systemic chemotherapy for the treatment of adenocarcinoma of the pancreas (with the exception of gemcitabine, fluorouracil, or capecitabine in the adjuvant setting).

• Laboratory abnormalities:

• Prior history of malignancy within 5 years (except basal or squamous cell carcinoma or carcinoma in situ of the cervix or breast, localized prostate cancer with PSA < 1,0 mg/dL).

• Subjects with a history of or active DVT or PE that are not therapeutically managed on a stable dose of appropriate anticoagulant.

• Brain metastases (subjects that are asymptomatic and do not require steroid control may be enrolled at the discretion of the investigator).

• Surgery within 28 days prior to cycle 1 Day 1 (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted, including stent placement and insertion of central venous access advice).

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

• Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent form.

• Prior therapy with lenalidomide or thalidomide.

• Use of any other experimental drug or therapy within 28 days prior to Cycle 1 Day 1.

• Pregnant or lactating females.