Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer

NCT01370876 | Terminated Phase 2 DMC

• 1 other identifier: 10CT006A
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.

Conditions

Cancer of the Head and Neck; Neoplasms, Head and Neck

Keywords

Oxaliplatin; Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer

  every 12 weeks

Secondary Outcomes (1)

• Safety

  Each patient will be followed for 30 days after the last dose of study medication

Study Arms (1)

Oxaliplatin/5-FU

EXPERIMENTAL

Drug: Oxaliplatin

Interventions

Oxaliplatin DRUG

Oxaliplatin will be administered as a 2-hour infusion first on Day 1, followed by 5-FU i.v. infusion for 48 hours (Day 1 and Day 2), repeated every 2 weeks, 4 weeks as a cycle.

Also known as: Opatin

Oxaliplatin/5-FU

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer.
• Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective.
• Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment.
• The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm.
• Patients must be 20 years of age and 75 years of age.
• Patients must have an ECOG performance status score 2.
• Patient's hematologic function, liver function and renal function must meet the eligibility requirements.
• Patients must sign the informed consent.

You may not qualify if:

• Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil.
• Patients with brain metastases.
• Patients with bone metastases only.
• Patients with pregnancy or breast-feeding.
• Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable.
• Patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion.
• Patients who are receiving other anticancer cancer drug(s) for SCCHN.

Sponsors & Collaborators

• Nang Kuang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taipei Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Chang Yi Fan, M.D.

  Taipei Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: June 10, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

TW (1)