Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

NCT00226239 | Completed Phase 2 Results DMC

• 1 other identifier: 05-003
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.

Conditions

Cancer

Keywords

head; neck

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.

  Up to 36 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to 36 months

• Progression-free Survival (PFS)

  Up to 36 months

• 2-year Overall Survival (OS)

  Up to 24 months

• 3-year Overall Survival (OS)

  Up to 36 months

• Quality of Life (QOL)

  Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE

Other Outcomes (1)

• EGFR-related Serum Markers

  Up to 36 months

Study Arms (1)

Head and neck cancer patients

EXPERIMENTAL

Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m\^2, on day 1, docetaxel 75 mg/m\^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m\^2 on day 1 and 250 mg/m\^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m\^2 and cetuximab 250 mg/m\^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)

Drug: Docetaxel; Drug: Cisplatin; Drug: Cetuximab; Procedure: Radiation Therapy

Interventions

Docetaxel DRUG

Docetaxel 75 mg/m\^2 IV over 1 hour, day 1

Head and neck cancer patients

Cisplatin DRUG

Cisplatin 75 mg/m\^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.

Head and neck cancer patients

Cetuximab DRUG

Cetuximab dose will be 250 mg/m\^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).

Also known as: (Erbitux or C225)

Head and neck cancer patients

Radiation Therapy PROCEDURE

Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies\>6 MV may be utilized when appropriate to boost target localized centrally.

Head and neck cancer patients

Eligibility Criteria

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

You may qualify if:

• Stage III-IVB head and neck cancer, all sites, including unknown primary tumors (bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with stage II nasopharyngeal cancer are also eligible) Prior to study entry the resectability and alternative treatment options will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Unequivocal demonstration of distant metastasis (M1) confers ineligibility
• Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or WHO types I-III of the nasopharynx
• Unidimensionally-measurable disease is required (RECIST)
• No prior chemotherapy, biologic/molecular targeted therapy (including any prior therapy which specifically and directly targets the EGFR pathway), or radiotherapy for head and neck cancer
• Prior surgical therapy will consist only of incisional or excisional biopsy and organ sparing procedures such as debulking of airway compromising tumors or neck dissection in a patient with an existing primary tumor (Any non-biopsy procedure must have taken place \> 4 weeks but \< 3 months of initiating protocol treatment)
• ECOG PS 0 or 1; 7. Organ \& marrow function per protocol criteria and 8. Age of \>=18 years

You may not qualify if:

• History of severe allergic reactions attributed to docetaxel or compounds of similar chemical or biologic composition to docetaxel, or other drugs formulated with polysorbate 80
• Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease
• Receiving any other investigational agents
• No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 5-year disease-free survival
• Significant baseline sensory or motor neurologic deficits (\> grade I neuropathy); 6. HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

  PMID: 25057165 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Docetaxel; Cisplatin; Cetuximab; Radiotherapy

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Results Point of Contact

• Title: Rita Johnson, Associate Director of Clinical Research Services
• Organization: UPMC Cancer Centers

johnsonr1@upmc.edu

412-647-8571

Study Officials

• Julie Bauman, MD

  Univ of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 22, 2005
• First Posted: September 26, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-04

Locations

US (1)