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CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas
This study is ongoing, but not recruiting participants.
First Received: October 5, 2007   Last Updated: June 24, 2009   History of Changes
Sponsor: Sarah Cannon Research Institute
Collaborator: Celgene Corporation
Information provided by: Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00540579
  Purpose

Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer is designed to determine the appropriate CC-4047 dose and regimen in combination with gemcitabine.


Condition Intervention Phase
Pancreas
Drug: CC-4047 and Gemcitabine
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas

Resource links provided by NLM:


Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • MTD [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 106
Study Start Date: November 2007
Estimated Study Completion Date: November 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CC-4047 and Gemcitabine

    Phase 1: Subjects will be enrolled in dose-escalating cohorts to be treated with CC-4047 on days 1-21 in combination with fixed doses of gemcitabine 1000 mg / m2 on days 1, 8, and 15 every 28 days.

    Phase II: Subjects will be enrolled to receive oral CC-4047 at the MTD days 1 - 21 in combination with fixed doses of gemcitabine 1000 mg / m2 days 1, 8, and 15 every 28 days.

Detailed Description:

Phase I

Primary:

• To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral CC-4047 given on days 1-21 in combination with gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.

Secondary:

• To explore the anti-tumor activity of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.

Phase II

Primary:

• To explore the anti-tumor activity of the combination of CC-4047 on days 1-21 and gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.

Secondary:

• To evaluate the safety profile of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.

  Eligibility

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

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age ≥ 18 years at the time of signing the informed consent form.
  3. Must be able to adhere to the study visit schedule and other protocol requirements.
  4. Histological or cytological documentation of adenocarcinoma of the pancreas with metastases not amenable to curative surgery or definitive radiation. Patients with locally advanced disease are not eligible.
  5. Radiographic or clinical evidence of measurable advanced metastatic pancreatic carcinoma. Subjects must have measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee for target lesions (see Appendix 14.2).
  6. Subjects may have been previously treated with adjuvant radiation therapy and 5-fluorouracil or Gemzar as a radiosensitizer in the adjuvant setting if they currently have evidence of progression. Following completion of XRT, no further adjuvant chemotherapy with either Gemzar or 5-FU is permitted. No prior Gemzar® for metastatic disease or for primary treatment of locally advanced disease is allowed. Gemzar® used solely as a radiation sensitizer in the adjuvant setting is permitted.
  7. ECOG performance status of 0 or 1.
  8. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and again within 24 hours of starting CC-4047 and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking CC-4047. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure (see Appendix 14.6).
  9. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
  10. Life expectancy of > 12 weeks
  11. Ability to swallow intact whole capsules of CC-4047

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. Any serious medical condition or psychiatric illness that prevents the study subject from signing the informed consent form or places the study subject at an unacceptable risk if he or she participates in the study.
  3. Prior therapy with CC-4047, lenalidomide, or thalidomide.
  4. Prior use of systemic therapy for the treatment of adenocarcinoma of the pancreas with the exception of 5-fluorouracil or Gemzar® as a radiosensitizer in the adjuvant setting
  5. Concurrent use of any other anti-cancer agents.
  6. 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 μmol/L)
    • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN); in case of liver metastases > 5 x ULN
    • Serum total bilirubin > 2.0 mg/dL (34 μmol/L)
  7. Surgery or radiation therapy within 14 days of study enrollment as outlined below.

    • Surgery within 14 days of the start of study (patients must have recovered from effects of surgery; 7 days may be considered for minor procedures).
    • Palliative radiation therapy within 14 days of the start of study. The radiation therapy may not be to the only site of measurable disease. Adjuvant therapy is permitted in accordance with the inclusion criteria.
  8. Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast, localized prostate cancer with PSA < 1.0 mg/dL) unless the subject has been free of disease for ≥ 3 years.
  9. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
  10. Grade ≥ 2 neuropathy.
  11. Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
  12. Use of any standard / experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
  13. Patients with a history of or active DVT or PE that are not therapeutically managed on a stable dose of appropriate anticoagulant
  14. New York Heart Association classification III or IV (see Appendix 14.7)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540579

Locations
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
Sarah Cannon Research Institute
Celgene Corporation
Investigators
Study Chair: Jeffrey Infante, M.D. Sarah Cannon Research Institute
  More Information

No publications provided

Responsible Party: SCRI Oncology Research Consortium ( Jeffrey Infante, M.D. )
Study ID Numbers: SCRI GI 105, PO-PANC-PI-009
Study First Received: October 5, 2007
Last Updated: June 24, 2009
ClinicalTrials.gov Identifier: NCT00540579     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sarah Cannon Research Institute:
Pancreas
Untreated
Advanced
Gemcitabine
CC-4047

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

ClinicalTrials.gov processed this record on February 08, 2010