Status:
TERMINATED
A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas
Lead Sponsor:
Celgene Corporation
Collaborating Sponsors:
Prologue Research International
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00179751
Start Date
April 1 2005
End Date
August 1 2006
Last Update
November 7 2005
Active Locations (6)
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1
Cancer and Blood Institute
Metairie, Louisiana, United States, 70006
2
Bernard Cancer Center
St Louis, Missouri, United States, 63110
3
Case Western Reserve University Hospitals Ireland Cancer Center
Cleveland, Ohio, United States, 44106
4
Charleston Cancer Center
Charleston, South Carolina, United States, 29406