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Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

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ClinicalTrials.gov Identifier: NCT01316757
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

March 8, 2011
March 16, 2011
February 26, 2018
February 16, 2011
April 7, 2015   (Final data collection date for primary outcome measure)
Objective response rate [ Time Frame: Up to 3 years ]
Complete plus partial response as determined by RECIST v 1.1
  • Baseline tumor measurements as assessed by CT Scan of the chest and MRI and CT Scan of the neck [ Time Frame: Baseline ]
    Measurable and non measurable tumor assessment as determined by RECIST v 1.1 less than 4 weeks prior to cycle 1
  • Pre treatment tumor assessment by CT Scan of the chest and MRI and CT Scan of the neck to measure change from baseline tumor status [ Time Frame: Beginning of cycle 2 ]
    Tumor assessment as determined by RECIST v 1.1 for best response following cycle 1. Patients with progressive disease may continue if deemed medically appropriate.
  • A change in tumor measurement as assessed by CT Scan of the chest and MRI and CT Scan of the neck following the following the start of the four drug measurement. [ Time Frame: beginning of cycle 4 ]
    Tumor response as determined by RECIST v 1.1. first achievement of partial response after cycle 2 and prior to the start of cycle 4 will be measured
  • Tumor measurement every 9 weeks as assessed by CT scan of the chest and MRI and CT Scan of the Neck [ Time Frame: end of cycle 4 ]
    Tumor assessment as determined by RECIST v 1.1.time to best response and best response status
Complete list of historical versions of study NCT01316757 on ClinicalTrials.gov Archive Site
  • Toxicity of study treatment [ Time Frame: Up to 30 days post-treatment ]
    Assessed by National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE) v.4.0. Proportions and 95% confidence intervals will be used.
  • Overall survival [ Time Frame: Up to 3 years ]
    Will use Kaplan-Meier curves.
  • EGFR assay levels [ Time Frame: Between courses 1 and 2 ]
    Will use a Wilcoxon paired-sample test.
  • Response rates [ Time Frame: Up to 3 years ]
    Proportions and 95% confidence intervals
  • Biomarkers related to EGFR [ Time Frame: Between courses 1 and 2 ]
    Will use Spearman correlations to assess the associations of the biomarkers with each other.
  • Safety and Tolerability [ Time Frame: Weekly and within 30 days of termination of study treatment ]
    Hematologic, skin rash, pulmonary events, diarrhea will be examined after the first 15 and first 30 patients (two interim points); the trial will be stopped early if death related to treatment occurs in 1 of the first 15 and 2 of the next 15 participants enrolled
  • Overall survival [ Time Frame: Every 3 months ]
  • EGFR assay levels [ Time Frame: Between courses 1 and 2 ]
    Investigate if EGFR assay levels in patients vary between cycle 1 (prior to erlotinib is added) and cycle two (after erlotinib is added)and perform similar tests for biomarkers related to EGFR. Spearman correlations will be used to assess associations of biomarkers with each other
  • Response rates [ Time Frame: At baseline, beginning of courses 2 and 4, and then every 9 weeks thereafter ]
    To be determined by measurement of target lesions according to RECIST criteria
  • Variation of biomarkers related to EGFR [ Time Frame: Between courses 1 and 2 ]
    Investigate if EGFR assay levels in patients vary between cycle 1 (prior to erlotinib is added) and cycle two (after erlotinib is added)and perform similar tests for biomarkers related to EGFR. Spearman correlations will be used to assess associations of biomarkers with each other
Not Provided
Not Provided
 
Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Phase II Trial of Carboplatin/Paclitaxel and Cetuximab, Followed by Carboplatin/Paclitaxel/Cetuximab and Erlotinib, With Correlative Studies in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck.
This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and erlotinib hydrochloride together works in treating patients with metastatic or recurrent squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with cetuximab and erlotinib hydrochloride may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To determine the objective response rate when erlotinib is added to combination carboplatin/paclitaxel/cetuximab systemic therapy in metastatic/recurrent head and neck cancer.

SECONDARY OBJECTIVES:

I. Secondary endpoints will be toxicity, overall survival, and laboratory correlates to determine if epidermal growth factor receptor (EGFR) signaling is more effectively inhibited after the addition of erlotinib than it is after chemotherapy/cetuximab without erlotinib.

OUTLINE:

Patients receive cetuximab intravenously (IV) over 60 minutes, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Salivary Gland Squamous Cell Carcinoma
  • Stage IV Salivary Gland Cancer
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Verrucous Carcinoma of the Larynx
  • Stage IV Verrucous Carcinoma of the Oral Cavity
  • Tongue Cancer
  • Untreated Metastatic Squamous Neck Cancer With Occult Primary
  • Biological: cetuximab
    Given IV
    Other Names:
    • C225
    • C225 monoclonal antibody
    • IMC-C225
    • MOAB C225
    • monoclonal antibody C225
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Drug: erlotinib hydrochloride
    Given PO
    Other Names:
    • CP-358,774
    • erlotinib
    • OSI-774
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment
Patients receive cetuximab IV over 60 minutes, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Biological: cetuximab
  • Drug: paclitaxel
  • Drug: carboplatin
  • Drug: erlotinib hydrochloride
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
43
October 3, 2017
April 7, 2015   (Final data collection date for primary outcome measure)

Criteria:

  • Histologically confirmed squamous cell carcinoma of the head and neck that is metastatic or recurrent
  • No prior systemic therapy for metastatic/recurrent disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Prior chemotherapy in the induction, organ preservation or adjuvant setting is permitted if it was completed more than 4 months prior to enrollment on the current study
  • Prior cetuximab is permitted if it was given for no more than 9 doses in combination with radiation therapy or chemoradiation therapy for initial treatment of locally advanced disease
  • No prior erlotinib, gefitinib or lapatinib therapy is permitted; nor is prior exposure to any investigational EGFR or panErbB reversible or irreversible inhibitor or any prior panitumumab or investigational EGFR-directed monoclonal antibody permitted
  • Hemoglobin > 9.0 G/dl
  • Absolute neutrophil count (ANC) > 1500 cells/mcl
  • Creatinine (Cr) < 1.8
  • Total bilirubin =< the institution's upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2 X ULN
  • No chronic active viral infection
  • No other malignancy within 3 years
  • No chronic diarrheal condition
  • Females should not be pregnant or breast feeding because chemotherapy may be harmful to the fetus or the nursing infant; also, the effects of erlotinib and cetuximab on the developing human fetus are unknown
  • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
  • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception while on treatment and for three months after the completion of treatment
  • Patients must have measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST); baseline measurements and evaluations must be obtained within < 4 weeks of randomization; all areas of disease should be recorded and mapped out in order to assess response and uniformity of response to therapy; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy; persistent disease without clear-cut progression after radiotherapy can be considered measurable if biopsy-proven at least 8 weeks after completion of radiation therapy
  • Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated; patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 3 years post diagnosis
  • No current peripheral neuropathy > grade 2 at time of randomization
  • Patients must not have any co-existing condition that would preclude full compliance with the study
  • Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib
  • Patients must have no history of allergic reaction to murine proteins
  • Ability to understand and the willingness to sign a written informed consent
  • Patients must not be receiving other investigational anti-cancer therapy
  • Patients with brain metastases are not eligible
  • Both men and women and members of all races and ethnic groups are eligible for this trial
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01316757
FER-HN-027
NCI-2011-00272 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA006927 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jessica Bauman, MD Fox Chase Cancer Center
Fox Chase Cancer Center
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP