A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas

Stopped early · Phase 1/Phase 2

Conditions studied: Pancreatic Cancer

In brief

Phase I will determine the MDT and evaluate the safety profile of oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, \& 15 in 28 day cycles Phase II will explore the anti-tumor activity and safety of the combination in subjects with advanced pancreatic carcinoma. Subjects will receive oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, \& 15 in 28 day cycles until documented disease progression occurs.

Key facts

Study ID

NCT00179751

Run by

Celgene Corporation

People needed

50

Starts

2005-04-01

Expected to finish

2006-08-01

Last updated by the study team

2005-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must understand and voluntarily sign an informed consent document.
• Age >or = to 18 years at the time of signing informed consent form.
• Subjects must be able to adhere to the study visit schedule and other protocol requirements.
• Histological documentation of advanced pancreatic carcinoma not amenable to curative surgery or definitive radiation.
• Radiographic or clinical evidence of measurable advanced pancreatic carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
• Subjects may have been previously treated with radiation therapy and 5-fluorouracil as a radiosensitizer in the adjuvant setting if they currently have evidence of progression.
• ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study medication.

You may not qualify if…

• Any of the following laboratory abnormalities:
• 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 (221 mmol/L)
• Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
• Serum total bilirubin >2.0 mg/dL (34 mmol/L)
• 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.
• Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for > or = to 1 year.
• Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
• Prior use of systemic therapy for the treatment of carcinoma of the pancreas with the exception of 5-fluorouracil as a radiosensitizer in the adjuvant setting.
• Concurrent use of any other anti-cancer agents.
• Any prior use of lenalidomide.
• Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
• Prior > or = to grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
• Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
• Pregnant or lactating females.

Where it is running

• Cancer and Blood Institute — Metairie, Louisiana, United States
• Bernard Cancer Center — St Louis, Missouri, United States
• Case Western Reserve University Hospitals Ireland Cancer Center — Cleveland, Ohio, United States
• Charleston Cancer Center — Charleston, South Carolina, United States
• Sarah Cannon Cancer Center — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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