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Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT02817113
Recruitment Status : Unknown
Verified June 2016 by Orient Europharma Co., Ltd..
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Collaborator:
NanoCarrier Co., Ltd.
Information provided by (Responsible Party):
Orient Europharma Co., Ltd.

Brief Summary:
NC-6004 is a polymeric micelle containing cisplatin as an active moiety. The nanoparticle provides sustained release of the active moiety and utilizes the enhanced permeability and retention (EPR) effect to target release of platinum to tumors. This Phase I study aims to establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell carcinoma of the head and neck for further clinical study development.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: NC-6004 Drug: Cetuximab Drug: 5-FU Phase 1

Detailed Description:
  1. Primary objectives

    ♦ To determine the Maximum Tolerated Dose (MTD) of NC-6004 according to the Dose Limiting Toxicity (DLT) in combination with 5-FU plus cetuximab as firstline treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), and to decide the RD for the following studies

  2. Secondary objectives 1). To evaluate the safety and tolerability profile of NC-6004 in combination with 5- FU plus cetuximab 2). To assess the pharmacokinetic effects of NC-6004 3). To assess the antitumor effects of NC-6004

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of NC-6004 in Combination With 5-FU and Cetuximab as First-line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NC-6004, Cetuximab and 5-FU
Cetuximab will be administered before the start of chemotherapy at a loading dose of 400 mg/m2 given, followed by a subsequent weekly doses of 250 mg/m2; NC-6004 will be administered on Day 1 every 3 weeks, and 5-FU will be administered at a dose of 1,000 mg/m2/day on Day 1- Day 4 as continuous infusion every 3 weeks.
Drug: NC-6004
One cycle of treatment lasts for 3 weeks. NC-6004 will be administered over 1 hour on Day 1 (after the cetuximab infusion) every 3 weeks
Other Names:
  • Micelplatin (Taiwan only)
  • Nanoplatin (Japan only)

Drug: Cetuximab
One cycle of treatment lasts for 3 weeks. For each cycle, cetuximab will be administered at least 1 hour before the start of chemotherapy at a loading dose of 400 mg/m2 given over 2 hours initially (ie, on the first day of treatment), followed by a subsequent weekly doses of 250 mg/m2 over 1 hour.
Other Name: Erbitux

Drug: 5-FU
One cycle of treatment lasts for 3 weeks. 5-FU will be administered at a dose of 1,000 mg/m2/day on Day 1- Day 4 as continuous infusion every 3 weeks.
Other Name: Fluorouracil




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 29 months ]
    MTD of NC-6004 according to the DLT when administered in combination with 5-FU plus cetuximab as first-line treatment


Secondary Outcome Measures :
  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 29 months ]
    According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 criteria

  2. Incidence of AE lead to treatment discontinuation [ Time Frame: 29 months ]
  3. Peak Plasma Concentration (Cmax) [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  4. Time of Maximum concentration observed (Tmax) [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  5. Area under the plasma concentration-time curve from time zero to time (AUC0-t) [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  6. Area under the concentration time-curves from time zero to infinity (AUC0-∞) [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  7. Terminal Elimination Rate Constant (λz) [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  8. Elimination Half-life (t½) [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  9. Clearance (CL) of total platinum in plasma [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  10. Clearance (CL) of total platinum in plasma ultrafiltrate [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  11. Volume of Distribution (Vz) of total platinum in plasma [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  12. Volume of Distribution (Vz) of total platinum in plasma ultrafiltrate [ Time Frame: Within 4 cycles (each cycle is 21 days) ]
  13. Tumor response rate (RR) [ Time Frame: 29 months ]
    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results

  14. Disease control rate (DCR) [ Time Frame: 29 months ]
    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results

  15. Overall response rate (ORR) [ Time Frame: 29 months ]
    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results


Other Outcome Measures:
  1. Changes in vital signs [ Time Frame: 29 months ]
    Arterial blood pressure, heart rate, respiratory rate and temperature are to be monitored during infusion.

  2. Changes in laboratory results [ Time Frame: 29 months ]
    Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.

  3. Physical examination findings [ Time Frame: 29 months ]
    Number of participants with physical examination abnormal findings that are related to treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Known (histology/cytology proven) or evidenced by radiology of recurrent and/or metastatic SCCHN not suited for local therapy
  • Males or females aged ≥ 20 years and < 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Life expectancy >12 weeks as judged by investigators
  • Adequate bone marrow reservation:
  • Adequate liver function:
  • Adequate renal function:
  • Reasonably recovered from preceding major surgery as judged by the Investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment

Exclusion Criteria:

  • Female of child-bearing potential who is or has intention to be pregnant or breastfeeding.
  • Previous radiotherapy within 3 months before study entry
  • Known brain metastasis or leptomeningeal involvement
  • Marked pleural effusion or ascites above Grade 2, based on NCI-CTCAE v4.03 criteria
  • History of thrombocytopenia with complications (including hemorrhage or bleeding ≥ Grade 2, based on NCI-CTCAE v4.03 criteria), hemolytic condition, or coagulation disorders that would make subjects unsafe based on the judgment of the Investigator
  • Patients who have unresolved toxicity from all radiation, adjuvant/neoadjuvant chemotherapy, other targeted treatment including investigational treatment (exception of alopecia and ≤ Grade 2 peripheral neuropathy) according to NCI-CTCAE v4.03 criteria
  • Known hypersensitivity to the study drugs or the drugs with similar chemical structures
  • History of myocardial infarction within 6 months before study entry, unstable congestive heart failure (New York Heart Association, NYHA Stage III-IV), angina pectoris, or transient ischemic attack or cardiac arrhythmia requiring medical therapy
  • History of any other cancer other than head and neck cancer (HNC) (except carcinoma in situ of the cervix) within the last 5 years.
  • Primary tumor of the nasopharynx (nasopharyngeal carcinoma)
  • Known HIV-1 or any active infection requiring IV antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817113


Contacts
Contact: Shirley Lin +886-2-23257621 ext 2922 shirley.lin@oppharma.com

Locations
Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Contact: Ruey-Long Hong, MD PhD         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Muh-Hwa Yang, MD PhD         
Chang Gung Memorial Hospital, Linkou Branch Recruiting
Taoyuan, Taiwan, 333
Contact: Hung-Ming Wang, MD PhD         
Sponsors and Collaborators
Orient Europharma Co., Ltd.
NanoCarrier Co., Ltd.
Investigators
Principal Investigator: Ruey-Long Hong, MD PhD National Taiwan University Hospital

Responsible Party: Orient Europharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02817113     History of Changes
Other Study ID Numbers: NC-6004-006
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs