A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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. []
- Phase II-To explore the anti-tumor activity of the combination of lenalidomide on days 1 - 21 and gemcitabine days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma. []
Secondary Outcome Measures
- Phase I-To explore the anti-tumor activity of the combination of lenalidomide and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma. []
- Phase II-To evaluate the safety profile of the combination of lenalidomide and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must understand and voluntarily sign an informed consent document.
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Age >or = to 18 years at the time of signing informed consent form.
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Subjects must be able to adhere to the study visit schedule and other protocol requirements.
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Histological documentation of advanced pancreatic carcinoma not amenable to curative surgery or definitive radiation.
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Radiographic or clinical evidence of measurable advanced pancreatic carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
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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.
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ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
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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:
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Any of the following laboratory abnormalities:
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Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
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Platelet count <100,000 cells/mm3 (100 x 109/L)
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Serum creatinine >2.5 mg/dL (221 mmol/L)
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Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
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Serum total bilirubin >2.0 mg/dL (34 mmol/L)
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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.
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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.
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Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
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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.
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Concurrent use of any other anti-cancer agents.
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Any prior use of lenalidomide.
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Prior > or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
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Prior > or = to grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
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Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
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Pregnant or lactating females.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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 |
5 | Sarah Cannon Cancer Center | Nashville | Tennessee | United States | 37203-1632 |
6 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Celgene Corporation
- Prologue Research International
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-5013-PANC-001