A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas
NCT ID: NCT00179751
Last Updated: 2005-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2005-04-30
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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CC-5013
gemcitabine
Eligibility Criteria
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Inclusion Criteria
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 requirements.
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 progression.
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. 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 thalidomide.
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.
18 Years
ALL
No
Sponsors
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Prologue Research International
INDUSTRY
Celgene Corporation
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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CC-5013-PANC-001
Identifier Type: -
Identifier Source: org_study_id