Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02043288
Previous Study | Return to List | Next Study

Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02043288
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
NanoCarrier Co., Ltd.
Information provided by (Responsible Party):
Orient Europharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 14, 2014
First Posted Date  ICMJE January 23, 2014
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
Overall survival (OS) [ Time Frame: 3.5 years ]
Overall survival is defined as the time from the treatment initiation until death from any cause, and censored at the last follow up time.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
  • Progression free survival (PFS) [ Time Frame: 3.5 years ]
    Progression free survival is defined as the time from the treatment initiation until progression or death, and censored at the last follow up time.
  • Response rate (RR) and disease control rate (DCR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria [ Time Frame: 3.5 years ]
    • Response rate is defined as counts and proportions of patients responding complete response or partial response within the duration of the study.
    • Disease control rate is defined as counts and proportions of patients responding complete response, partial response or progressive disease within the duration of the study.
  • Duration of response [ Time Frame: 3.5 years ]
    • Duration of overall response (DOR) will be measured from the time of initial response (CR or PR) until documented progression or death, and censored at last follow up time.
    • Duration of stable disease (DSD) will be measured from the time of initial stable disease (SD) until documented progression or death, and censored at last follow up time.
  • CA19-9 [ Time Frame: 3.5 years ]
    CA19-9 values and changes from baseline will be summarized.
  • Quality of life (QoL) using EORTC QLQ-C30 [ Time Frame: 3.5 years ]
    Quality of life (QoL) values and changes from baseline will be summarized.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer
Official Title  ICMJE A Phase III, Open-label, Randomized Study of the Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Brief Summary This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countries.
Detailed Description

Pancreatic cancer is one of the most deadly cancers because of the predominately late diagnosis. Gemcitabine (GEM) is the standard treatment for advanced and metastatic pancreatic cancer. According to preclinical data and few early phase studies, a combined use of gemcitabine and cisplatin (CDDP) showed synergistic efficacy against pancreatic cancer. NC-6004, a novel micellar cisplatin formulation, retains the activity but avoids the renal toxicity and neurotoxicity caused by the high peak Cmax concentrations of cisplatin. This trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer.

The main hypothesis of this study is that NC-6004 plus gemcitabine combination is superior to gemcitabine alone in terms of overall survival in locally advanced or metastatic pancreatic cancer patients

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neoplasms
Intervention  ICMJE
  • Drug: NC-6004

    Study group (3 week/cycle):

    NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1

    Other Name: Micelplatin
  • Drug: Gemcitabine

    Study group (3 week/cycle):

    Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004)

    Control group (4 week/cycle):

    Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15

    Other Name: Gemzar
Study Arms  ICMJE
  • Experimental: NC-6004 and Gemcitabine combination
    NC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively
    Interventions:
    • Drug: NC-6004
    • Drug: Gemcitabine
  • Active Comparator: Gemcitabine monotherapy
    Gemcitabine 1000mg/m2 i.v. on Day 1 ,8 and 15
    Intervention: 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: April 14, 2020)
310
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2014)
290
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Male or female aged between 20 to 80 years (inclusive)
  2. Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer (adenocarcinoma, adenosquamous carcinoma or poorly differentiated carcinoma)
  3. Presence of at least one measurable tumor lesion (longest diameter ≥ 10 mm)
  4. No prior systemic anti-cancer therapy* and radiotherapy** for advanced pancreatic cancer

    * Patients with post-operative adjuvant chemotherapy other than platinum products (e.g. cisplatin, carboplatin and oxaliplatin, etc.) or radiotherapy or chemo-radiotherapy completed more than 6 months before recurrence will be eligible.

    ** Patients with prior palliative radiotherapy of < 20% bone marrow involvement prior to 6 months from screening will be eligible.

  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  6. Adequate organ function defined as:

    • 3,000 cells/μL ≤ WBC ≤ 12,000 cells/μL
    • Absolute neutrophils count (ANC) ≥ 1,500 cells/μL
    • Platelets ≥ 100,000 cells/μL
    • Hemoglobin (Hb) ≥ 9.0 g/dL
    • Alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤ 2.5 times the upper limit of normal (ULN) in patients with no demonstrable hepatic metastasis, or ≤ 5 x ULN in patients with hepatic metastasis
    • Serum bilirubin ≤ 1.5 x ULN in patients with no demonstrable hepatic metastasis and obstructive jaundice, or ≤ 2.5 x ULN in patients with hepatic metastasis or obstructive jaundice
    • Serum creatinine (SCr) ≤ 1.5 mg/dL and creatinine clearance (CrCl) ≥ 60 mL/min (from 24-hour urine test or Cockcroft-Gault formula)
    • Corrected serum calcium ≤ ULN
  7. If fertile*, willing to use barrier contraception till 6 months after the end of treatment

    * With the following exceptions: 1) pre-menopausal females with bilateral tubal ligation, bilateral oophorectomy or hysterectomy; 2) post-menopausal women, defined as 12 months of spontaneous amenorrhea; 3) males with vasectomy.

  8. Willing and able to comply with study procedures and provide written informed consent

Exclusion criteria:

  1. Pregnancy or breastfeeding
  2. Active concomitant malignancy or history of other cancer except carcinoma in situ of cervical squamous cell carcinoma, stage I colon cancer or other malignance that has remained disease-free for more than 3 years after curative intervention
  3. Metastasis to the central nervous system or brain
  4. Evidence of hearing impaired ≥ Grade 2 as assessed by pure tone audiometry or other neurotoxicity ≥ Grade 2

    * Patients with age-associated hearing loss at the high frequencies that, in the judgment of the investigator, would not interfere significantly with patient's safety or study assessments will be eligible to enroll.

  5. Patient with pulmonary fibrosis or interstitial pneumonia
  6. Marked pleural effusion or ascites above Grade 2
  7. Patient with known HIV infection
  8. Patient with active hepatitis B, hepatitis C or any other ongoing severe infections
  9. Patient with severe mental disorder
  10. As judged by the investigator, any evidence of significant laboratory findings or severe/uncontrolled clinical disorders (e.g. dementia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, and other unstable or uncompensated respiratory, cardiac, hepatic, renal and/or infectious disease)
  11. Patient with known hypersensitivity to Pt compounds
  12. Known severe drug hypersensitivity
  13. Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment
  14. Alcoholic liver disease* or liver disease with obvious clinical symptom or sign

    * the investigator should judge from medical examination by interview and laboratory test including γ-GTP, AST and ALT

  15. Daily Alcohol consumption within 6 months before the screening as an average weekly intake of >21 units (168 g of pure alcohol) or an average daily intake of >3 units (24 g of pure alcohol) for males / an average weekly intake of >14 units (112 g of pure alcohol) or an average daily intake of >2 units (16 g of pure alcohol) for females.

    Kind of Alcohol Alcohol Percentage mL per 1 unit =8 g of pure alcohol

    Beer 5 % 200 mL

    Whiskey/Brandy 40 % 25 mL

    Wine 12 % approx. 83 mL

    Sake 15 % approx. 67 mL

    Distilled spirit 25 % 40 mL

    Kaoliang 50 % 20 mL

  16. Patient with uncontrolled diabetes
  17. Radiotherapy within 6 months before screening
  18. Experienced Abdominal Radiotherapy
  19. Experienced treatment of Gemtuzumab ozogamicin
  20. Patient with autoimmune hepatitis or idiopathic thrombocytopenic purpura (ITP)
  21. Observation of "attenuated or reversed hepatic venous portal blood flow*" was confirmed by doppler ultrasonography or CT (recommend evaluation in arterial phase, portal-venous phase and equilibrium phase) of the liver * On doppler ultrasonography of right and left branch of portal vein, blood flow is measured as about 0 mL/min or between plus and minus, which indicate obvious blood flow obstruction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (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 Hong Kong,   Japan,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02043288
Other Study ID Numbers  ICMJE NC-6004-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Orient Europharma Co., Ltd.
Study Sponsor  ICMJE Orient Europharma Co., Ltd.
Collaborators  ICMJE NanoCarrier Co., Ltd.
Investigators  ICMJE
Principal Investigator: Li-Tzong Chen, M.D., Ph. D. National Institute of Cancer Research, National Health Research Institutes
PRS Account Orient Europharma Co., Ltd.
Verification Date April 2020

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