Cetuximab, Carboplatin, and Paclitaxel Followed by Radiation Therapy, With or Without Cisplatin, in Treating Patients With Metastatic Head and Neck Cancer

NCT00301028 | Completed Phase 2 Results

• 6 other identifiers: 2003-0919P50CA097007P30CA016672MDA-2003-0919BMS-CA225054CDR0000441273
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy, with or without cisplatin, may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating patients with metastatic head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the lip and oral cavity

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response

  Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.

  Study period of 3 Years

Study Arms (1)

Cetuximab + Carboplatin/Paclitaxel

EXPERIMENTAL

Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin area under the curve (AUC) 2 and Paclitaxel 135 mg/m\^2 for 6 courses.

Biological: Cetuximab; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Conventional Surgery; Radiation: Radiation Therapy

Interventions

Cetuximab BIOLOGICAL

Beginning weekly dose 400 mg/m\^2 IV over 1-2 hours, and 250 mg/m\^2 weeks 2-6.

Also known as: C225, Erbitux, IMC-C225

Cetuximab + Carboplatin/Paclitaxel

Carboplatin DRUG

AUC 2 weekly for 6 courses.

Also known as: Paraplatin

Cetuximab + Carboplatin/Paclitaxel

Paclitaxel DRUG

135 mg/m\^2 weekly for 6 courses.

Also known as: Taxol

Cetuximab + Carboplatin/Paclitaxel

Conventional Surgery PROCEDURE

Following induction in second part of study.

Cetuximab + Carboplatin/Paclitaxel

Radiation Therapy RADIATION

Following induction in second part of study.

Also known as: Radiotherapy, RT, XRT

Cetuximab + Carboplatin/Paclitaxel

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx.
• Patients should have stage IV disease, stage T0-4 N2b/2c/3 M0 (for nasopharynx patients, stage N1 disease is eligible). Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) is required.
• Patients with stage Tx primary disease are eligible if there is N2b/3 adenopathy.
• Karnofsky performance status of \>/= 80 or Eastern Cooperative Oncology Group (ECOG) point scale 0-1
• Age \> 16 years
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 1500 cells/mm3 and platelet count of \> 100,000 cells/mm3; adequate hepatic function with bilirubin \</= Upper Limit of Normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4\* ULN if SGPT and SGOT are normal. Patients who have both SGPT and SGOT \> 1.5 ULN and alkaline phosphatase \> 2.5 \* ULN are not eligible. Normal PT/PTT and normal serum calcium (without intervention) are required.
• Creatinine clearance \> 40 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) times (weight in kg)/serum Cr times 72 CrCl female = 0.85 times (CrCl male)
• Patients should have no serious acute or chronic co-morbid condition, or acute infection.
• Patients must sign a study-specific informed consent form.

You may not qualify if:

• Histology other than squamous cell carcinoma.
• Evidence of distant metastases (below the clavicle) by clinical or radiographic means.
• Karnofsky performance status \< 80 or ECOG\>1
• Prior chemotherapy, within the previous 3 years.
• Prior radiotherapy to the head and neck.
• Prior cetuximab therapy, prior therapy with any other drug that targets the EGFR pathway, or prior therapy with a murine or chimeric monoclonal antibody.
• Initial surgical resection rendering the patient clinically and radiologically disease free.
• Simultaneous primary invasive cancers.
• Patients with another malignancy (excluding non melanoma skin cancers, and cancers treated \> 3 years prior for which patient remains continuously disease free).
• Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 72 hours prior to the start of study medication.
• WOCBP using a prohibited contraceptive method.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• Refusal to sign the informed consent.
• Pre-existing peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or worse.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (2)

• Kies MS, Holsinger FC, Lee JJ, William WN Jr, Glisson BS, Lin HY, Lewin JS, Ginsberg LE, Gillaspy KA, Massarelli E, Byers L, Lippman SM, Hong WK, El-Naggar AK, Garden AS, Papadimitrakopoulou V. Induction chemotherapy and cetuximab for locally advanced squamous cell carcinoma of the head and neck: results from a phase II prospective trial. J Clin Oncol. 2010 Jan 1;28(1):8-14. doi: 10.1200/JCO.2009.23.0425. Epub 2009 Nov 16.

  PMID: 19917840 RESULT

• 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

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

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

Interventions

Cetuximab; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Merrill S. Kies, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Merrill S. Kies, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

• Vassiliki A. Papadimitrakopoulou, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: March 8, 2006
• First Posted: March 10, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 5, 2013
• Results First Posted: April 5, 2013

Record last verified: 2013-02

Locations

US (1)