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A Phase I/II Study Of Lenalidomide (Revlimid™) In Combination With Gemcitabine In Patients With Untreated Advanced Carcinoma Of The Pancreas

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase I/II Study Of Lenalidomide (Revlimid™) In Combination With Gemcitabine In Patients With Untreated Advanced Carcinoma Of The Pancreas

Inclusion Criteria:

1. Subjects must understand and voluntarily sign an informed consent document.

2. Age >or = to 18 years at the time of signing informed consent form.

3. Subjects must be able to adhere to the study visit schedule and other protocol

4. Histological documentation of advanced pancreatic carcinoma not amenable to curative
surgery or definitive radiation.

5. Radiographic or clinical evidence of measurable advanced pancreatic carcinoma.
Subjects must have measurable disease at least 2 cm in diameter.

6. 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

7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).

8. 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.

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)

2. Platelet count <100,000 cells/mm3 (100 x 109/L)

3. Serum creatinine >2.5 mg/dL (221 mmol/L)

4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)

5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)

2. 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.

3. 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.

4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in
case of clinical suspicion of central nervous system involvement).

5. 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.

6. Concurrent use of any other anti-cancer agents.

7. Any prior use of lenalidomide.

8. Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to

9. Prior > or = to grade 3 (see Appendix III) rash or any desquamating (blistering)
rash while taking thalidomide.

10. Use of any standard/experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy.

11. Pregnant or lactating females.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I-To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral lenalidomide days 1- 21 in combination with gemcitabine days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

August 2006

Related Keywords:

  • Pancreatic Cancer
  • cc-5013
  • revlimid
  • pancreatic cancer
  • Carcinoma
  • Pancreatic Neoplasms



Cancer and Blood InstituteMetairie, Louisiana  70006
Charleston Cancer CenterCharleston, South Carolina  29406
Sarah Cannon Cancer CenterNashville, Tennessee  37203
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Bernard Cancer CenterSt. Louis, Missouri  63110
Case Western Reserve University Hospitals Ireland Cancer CenterCleveland, Ohio  44106