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

This study has been terminated.
Sponsor:
Collaborator:
Prologue Research International
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00179751
First received: September 10, 2005
Last updated: November 2, 2005
Last verified: November 2005
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: CC-5013
Drug: gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study Of Lenalidomide (Revlimid™) In Combination With Gemcitabine In Patients With Untreated Advanced Carcinoma Of The Pancreas

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

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.

Estimated Enrollment: 50
Study Start Date: April 2005
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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. 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179751

Locations
United States, Louisiana
Cancer and Blood Institute
Metairie, Louisiana, United States, 70006
United States, Missouri
Bernard Cancer Center
St. Louis, Missouri, United States, 63110
United States, Ohio
Case Western Reserve University Hospitals Ireland Cancer Center
Cleveland, Ohio, United States, 44106
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203-1632
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00179751     History of Changes
Other Study ID Numbers: CC-5013-PANC-001
Study First Received: September 10, 2005
Last Updated: November 2, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
cc-5013
revlimid
pancreatic cancer

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gemcitabine
Lenalidomide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 26, 2014