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Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas

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ClinicalTrials.gov Identifier: NCT00837031
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Tracking Information
First Submitted Date  ICMJE February 4, 2009
First Posted Date  ICMJE February 5, 2009
Results First Submitted Date  ICMJE February 8, 2013
Results First Posted Date  ICMJE March 13, 2013
Last Update Posted Date March 13, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment [ Time Frame: 6 months ]
The percentage of patients who were alive 6 months after beginning treatment
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
  • To confirm the safety and tolerability (during the lead-in portion of the study) of gemcitabine in combination with lenalidomide based on the incidence of dose-limiting toxicities (DLTs) in patients with advanced pancreatic carcinoma. [ Time Frame: 18 months ]
  • To explore the anti-tumor activity of the combination of lenalidomide given on Days 1-21 and gemcitabine given on Days 1, 8, and 15 every 28 days in patients with advanced pancreatic carcinoma. [ Time Frame: 18 months ]
Change History Complete list of historical versions of study NCT00837031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
  • Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]
    The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
  • Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]
    Length of time, in months, that patients were alive from their first date of protocol treatment until death
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
To evaluate the response rate, duration of response, progression-free survival (PFS), overall survival, safety, and pain score of the combination of lenalidomide and gemcitabine in patients with advanced pancreatic carcinoma. [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas
Official Title  ICMJE A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas
Brief Summary To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer.
Detailed Description Because the activity of lenalidomide addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - lenalidomide is being evaluated as part of induction chemotherapy regimens for solid tumors. This phase II study in previously untreated metastatic pancreatic cancer is designed to establish and test the appropriate lenalidomide dose and regimen in combination with gemcitabine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • Drug: Lenalidomide
    The starting dose of lenalidomide for the lead-in portion will be 25 mg orally daily on Days 1-21, followed by a 7-day rest period (28-day cycle). If the 25-mg dose of lenalidomide is found to be intolerable or unsafe (i.e., if more than one of the 6 patients experience a DLT), then the dose will be reduced to 20 mg orally daily, and 6 additional patients will be treated. All patients will receive lenalidomide at the confirmed tolerable dose (either 25 mg or 20 mg given orally daily on Days 1-21 of a 28-day cycle) until disease progression. If the 20-mg daily dose is found to be intolerable or unsafe, enrollment will be put on hold.
    Other Name: Revlimid
  • Drug: Gemcitabine
    Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.
    Other Name: Gemzar
Study Arms  ICMJE Experimental: Intervention

The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15).

After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.

Interventions:
  • Drug: Lenalidomide
  • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2013)
72
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2009)
70
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Understand and voluntarily sign the informed consent form.
  2. Patients >=18 years of age at the time of signing the informed consent form.
  3. Ability 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. Patients must have measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions.
  6. Previous gemcitabine or 5-fluorouracil (5-FU) with radiation therapy as adjuvant therapy is permitted. Extended use of gemcitabine or 5-FU after completion of adjuvant radiation therapy is not permitted. No prior gemcitabine for metastatic disease or for primary treatment of locally advanced disease is allowed.
  7. ECOG performance status of <=2 at study entry.
  8. Laboratory test results within these ranges:

    • 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
    • Total bilirubin <=2.0 mg/dL
    • AST (SGOT) and ALT (SGPT) <=3.0 x ULN or <=5 x ULN if hepatic metastases are present.
  9. Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast, or localized prostate cancer with PSA <1.0 ng/mL), unless the patient has been free of disease for >=3 years.
  10. All study participants must be registered into the mandatory RevAssist® program, and must be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

  1. Prior use of systemic therapy for the treatment of adenocarcinoma of the pancreas, with the exception of 5-fluorouracil or gemcitabine as a radiosensitizer in the adjuvant setting.
  2. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
  3. Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide).
  4. Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  5. 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.
  6. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
  7. Neuropathy of ≥ grade 2.
  8. Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00837031
Other Study ID Numbers  ICMJE SCRI GI 106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SCRI Development Innovations, LLC
Study Sponsor  ICMJE SCRI Development Innovations, LLC
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Study Chair: Jeffrey R Infante, M.D. SCRI Development Innovations, LLC
PRS Account SCRI Development Innovations, LLC
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP