NCT01064479 · REGISTRY CONDITION SEARCH

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-07-16

This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])

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outcome · POSTED

Disease Control (CR + PR + Stable Disease [SD])

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outcome · POSTED

Rash Rates

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx, hypopharynx or larynx; metastatic or recurrent lesions of the nasopharynx and sinus are excluded * Radiologically measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan; measurable lymph nodes are required to be \>= 15 mm in size (short axis diameter) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2 * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelet count \>= 100 x 10\^9/L * Total bilirubin =\< upper limit of normal (ULN) (excluding Gilbert's disease) * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x ULN * Alkaline phosphatase =\< 2.5 x ULN * Serum creatinine =\< 1.5 x ULN * Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =\< 14 days prior to treatment initiation * Written informed consent to participate in the study according to the investigational review board (IRB) or independent ethics committee (IEC) Exclusion Criteria: * Histology other than squamous cell carcinoma * Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx * Prior palliative chemotherapy for metastatic or recurrent disease * Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to randomization * Patients with known, untreated brain metastases; patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed more than 28 days prior to study entry and if clinical neurologic function is stable * Pre-existing peripheral neuropathy \>= grade 2 * History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis); patients requiring feeding tubes are permitted * Other active malignancies requiring chemotherapy treatment within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial, resected melanoma * Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician * History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80 * Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer * Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent * Women who are pregnant or breast-feeding and women or men not practicing effective birth control
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
intervention Names
Drug: Carboplatin
Drug: Cisplatin
Drug: Docetaxel
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Quality-of-Life Assessment
label
Arm A (combination chemotherapy and erlotinib hydrochloride)
type
EXPERIMENTAL
description
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
intervention Names
Drug: Carboplatin
Drug: Cisplatin
Drug: Docetaxel
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Placebo
Other: Quality-of-Life Assessment
label
Arm B (combination chemotherapy and placebo)
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Arm A (combination chemotherapy and erlotinib hydrochloride)
Arm B (combination chemotherapy and placebo)
description
Given IV
name
Carboplatin
other Names
Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
type
DRUG
arm Group Labels
Arm A (combination chemotherapy and erlotinib hydrochloride)
Arm B (combination chemotherapy and placebo)
description
Given IV
name
Cisplatin
other Names
Abiplatin
Blastolem
Briplatin
CDDP
Cis-diammine-dichloroplatinum
Cis-diamminedichloridoplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
type
DRUG
arm Group Labels
Arm A (combination chemotherapy and erlotinib hydrochloride)
Arm B (combination chemotherapy and placebo)
description
Given IV
name
Docetaxel
other Names
Docecad
RP56976
Taxotere
Taxotere Injection Concentrate
type
DRUG
arm Group Labels
Arm A (combination chemotherapy and erlotinib hydrochloride)
description
Given PO
name
Erlotinib Hydrochloride
other Names
Cp-358,774
OSI-774
Tarceva
type
DRUG
arm Group Labels
Arm A (combination chemotherapy and erlotinib hydrochloride)
Arm B (combination chemotherapy and placebo)
description
Optional correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Arm A (combination chemotherapy and erlotinib hydrochloride)
Arm B (combination chemotherapy and placebo)
description
Optional correlative studies
name
Pharmacological Study
type
OTHER
arm Group Labels
Arm B (combination chemotherapy and placebo)
description
Given PO
name
Placebo
other Names
placebo therapy
PLCB
sham therapy
type
OTHER
arm Group Labels
Arm A (combination chemotherapy and erlotinib hydrochloride)
Arm B (combination chemotherapy and placebo)
description
Ancillary studies
name
Quality-of-Life Assessment
other Names
Quality of Life Assessment
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
INVESTIGATOR

primary Purpose

TREATMENT

Enrollment

count: 123
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
measure
Progression Free Survival (PFS)
time Frame
5 years

secondary Outcomes

description
Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals.
measure
Overall Survival (OS)
time Frame
5 years
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
measure
Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
time Frame
5 years
description
Complete Response (CR) + Partial Response (PR) + Stable disease
measure
Disease Control (CR + PR + Stable Disease [SD])
time Frame
5 years
description
Participants with a Rash of at least grade 2 within cycle 1.
measure
Rash Rates
time Frame
5 years

Full study description

brief Summary: This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.
detailed Description: PRIMARY OBJECTIVES: I. Assess the efficacy of adding erlotinib hydrochloride (erlotinib) to chemotherapy to improve progression free survival in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. Evaluate overall survival, response rate, disease control rate, and duration of response by treatment with or without erlotinib. II. Evaluate quality of life (patient reported outcomes) by treatment with or without erlotinib. III. Evaluate the safety profile of erlotinib in combination with chemotherapy. IV. Correlate the occurrence of erlotinib-induced rash with outcomes. V. To evaluate the steady-state pharmacokinetics of erlotinib. VI. To explore the prognostic and predictive value of epidermal growth factor receptor related biomarkers and other biomarkers, including blood and tissue proteomic and blood and tissue genomic markers, that may be associated with clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive docetaxel intravenously (IV) over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1, and erlotinib hydrochloride orally (PO) daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment. ARM B: Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment. After completion of study treatment, patients are followed up at 30 days.

Source references