Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer
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| ClinicalTrials.gov Identifier: NCT00055770 |
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Recruitment Status :
Completed
First Posted : March 7, 2003
Last Update Posted : November 25, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 Salivary Gland Squamous Cell Carcinoma Stage III Salivary Gland Cancer Stage III Squamous Cell Carcinoma of the Hypopharynx Stage III Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity Stage III Squamous Cell Carcinoma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity 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 | Drug: erlotinib hydrochloride Drug: docetaxel Other: laboratory biomarker analysis Other: pharmacological study | Phase 1 Phase 2 |
OBJECTIVES:
I. Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered in combination with docetaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.
II. Determine the response rate, duration of response, time to progression, and survival of patients treated with this regimen.
III. Determine the pharmacokinetics of this regimen in these patients. IV. Correlate the presence of PTEN, RB, P-Akt, p15, p16, cyclin D1, p27, and p53 genes in tumor tissue with response in patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of erlotinib followed by a phase II study.
PHASE I: Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1 hour on days 8, 15, and 22. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients receives erlotinib at the MTD.
PHASE II: Patients receive erlotinib at the MTD and docetaxel as in phase I.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 45 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I and Phase II Study of OSI-774 in Combination With Docetaxel in Squamous Cell Carcinoma of the Head and Neck |
| Study Start Date : | October 2002 |
| Actual Primary Completion Date : | December 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
PHASE I: Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1 hour on days 8, 15, and 22. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients receives erlotinib at the MTD. PHASE II: Patients receive erlotinib at the MTD and docetaxel as in phase I. |
Drug: erlotinib hydrochloride
Given orally
Other Names:
Drug: docetaxel Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies Other: pharmacological study Correlative studies
Other Name: pharmacological studies |
- Maximum tolerated dose of erlotinib and docetaxel, based on incidence of DLT graded according to NCI CTC version 2.0 (Phase I) [ Time Frame: Up to 28 days ]
- Proportion of patients with an objective response (Phase II) [ Time Frame: Up to 6 years ]
- Response rate as measured by RECIST criteria (Phase II) [ Time Frame: Up to 6 years ]
- Time to tumor progression (Phase II) [ Time Frame: Up to 6 years ]
- Median survival (Phase II) [ Time Frame: Up to 6 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Histologically or cytologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following staging criteria:
- Recurrent
- Metastatic
- Locally advanced and determined to be incurable by surgery or radiotherapy
- Measurable disease
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No severe pulmonary insufficiency, including chronic obstructive pulmonary disease, requiring oxygen (O2 saturation less than 90%) and/or increase in PaCO2 blood gas level greater than 50 mm Hg
- No history of abnormality of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
- No congenital abnormality (e.g., Fuch's dystrophy)
- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- Able to take oral medication
- No requirement for IV alimentation
- No active peptic ulcer disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant traumatic injury within the past 21 days
- No prior allergic reactions to compounds of similar chemical or biological composition to study drugs
- No grade 2 or greater persistent peripheral neuropathy
- No other concurrent uncontrolled illness that would preclude study participation
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No prior immunotherapy for head and neck cancer
- No more than 1 prior chemotherapy regimen in the adjuvant or neoadjuvant setting
- No more than 1 prior chemotherapy regimen for metastatic disease
- No prior docetaxel (phase II only)
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior hormonal therapy for head and neck cancer
- Prior external beam radiotherapy allowed
- At least 4 weeks since prior radiotherapy and recovered
- More than 21 days since prior major surgery
- No prior surgery affecting gastrointestinal absorption
- No prior epidermal growth factor receptor-targeting therapy
- No other concurrent investigational agents
- No other concurrent anticancer therapies or agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055770
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | Eric Kraut | Ohio State University |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00055770 History of Changes |
| Other Study ID Numbers: |
NCI-2012-01432 NCI-2012-01432 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) OSU-0213 NCI-5393 CDR0000271197 OSU-02H0084 OSU 0213 ( Other Identifier: Ohio State University Medical Center ) 5393 ( Other Identifier: CTEP ) U01CA076576 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 7, 2003 Key Record Dates |
| Last Update Posted: | November 25, 2013 |
| Last Verified: | November 2013 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Laryngeal Diseases Laryngeal Neoplasms Oropharyngeal Neoplasms Nasopharyngeal Neoplasms Salivary Gland Neoplasms Paranasal Sinus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Respiratory Tract Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms |
Head and Neck Neoplasms Neoplasms by Site Respiratory Tract Neoplasms Pharyngeal Neoplasms Pharyngeal Diseases Stomatognathic Diseases Nasopharyngeal Diseases Mouth Neoplasms Mouth Diseases Salivary Gland Diseases Nose Neoplasms Nose Diseases Paranasal Sinus Diseases Docetaxel Erlotinib Hydrochloride |