Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

NCT00591149 | Terminated Phase 2 Results DMC

• 1 other identifier: 10635
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Conditions

Head and Neck Cancer; Carcinoma, Squamous

Keywords

cancer; head and neck cancer; squamous cell cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy Measured by Response Rate in Participants

  Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: * Complete Response (CR), Disappearance of all target lesions; * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  12 Weeks, 1 Year

Study Arms (1)

1

EXPERIMENTAL

Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.

Drug: Oxaliplatin; Drug: Docetaxel; Drug: Cetuximab

Interventions

Oxaliplatin DRUG

130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles

Also known as: Eloxatin

1

Docetaxel DRUG

60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles

Also known as: Taxotere

1

Cetuximab DRUG

400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks

Also known as: Erbitux

1

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed recurrent SCCHN
• years or older
• Tumor site accessible by biopsy
• Measurable disease
• Receiving no other therapy
• ECOG performance status 0-1
• Adequate bone marrow, renal function and hepatic function

You may not qualify if:

• Active infection or fever within 3 days of treatment
• Active CNS metastases
• Prior malignancy within 5 years
• Hypersensitivity to study drugs
• Chemotherapy within 30 days of treatment
• Concurrent investigational therapy within 30 days
• Radiotherapy of more than 25% of bone marrow
• Peripheral neuropathy of grade 2 or greater
• Pregnant or lactating patients
• History of allogeneic transplant
• Active or previously treated HIV or Hepatitis B or C
• Patients with a tracheostomy

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Sanofi: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Neoplasms; Neoplasms, Squamous Cell

Interventions

Oxaliplatin; Docetaxel; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chao Huang, MD
• Organization: University of Kansas Medical Center

chuang2@kumc.edu

913-588-6029

Study Officials

• Chao Huang, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: June 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Locations

US (1)