Neoplasms

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Laryngeal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Laryngeal Cancer

Hypopharyngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Carboplatin

Docetaxel

Cisplatin

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

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.

Laboratory Biomarker Analysis

Pharmacological Study

Placebo

Quality-of-Life Assessment

Xiuning Le

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.

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.

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

A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel and Cisplatin/Carboplatin With or Without Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

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.

Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals.

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

Complete Response (CR) + Partial Response (PR) + Stable disease

Participants with a Rash of at least grade 2 within cycle 1.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)

Arm B (Combination Chemotherapy and Placebo)

Total

Age, Categorical

Sex: Female, Male

The race and ethnicity were reported for participants. The data collected was for all participants and not separated in each arm.

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Xiuning Le, MD, Assistant Professor, Thoracic-Head & Neck Med Onc

Progression Free Survival (PFS)

Overall Survival (OS)

Complete Response

Partial Response

Progressive Disease

Stable Disease

Inevaluable

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

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

Rash Rates

Overall Study

Paclitaxel

Albumin-Bound Paclitaxel

Sorafenib

Participants receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1, and sorafenib PO BID on days 2-19. Treatment repeats every 21 days for up to 6 courses. Starting with course 7, participants receive sorafenib PO daily in the absence of disease progression or unacceptable toxicity.

George Blumenschein, MD

This phase II trial studies how well sorafenib works with carboplatin and paclitaxel in treating participants with head and neck squamous cell cancer that has spread to other parts of the body or that has come back. Drugs used in chemotherapy, such as sorafenib, carboplatin, and paclitaxel, 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.

PRIMARY OBJECTIVES:

I. To evaluate the progression free survival of the combination of sorafenib (BAY 43-9006), carboplatin, and paclitaxel in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).

SECONDARY OBJECTIVES:

I. Response rate, toxicity, safety profile, exploratory biomarker data, and overall survival.

OUTLINE:

Participants receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3 hours on day 1, and sorafenib orally (PO) twice daily (BID) on days 2-19. Treatment repeats every 21 days for up to 6 courses. Starting with course 7, participants receive sorafenib PO daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up between 21-35 days.

Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

A Phase II Study of Sorafenib in Combination With Carboplatin and Paclitaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer

The rate of response to the treatment will be estimated, and the 95% confidence interval will be calculated.

Kaplan-Meier estimates of time to progression will be provided. Time to progression will be calculated from the first date of receiving study drug until documented progressive disease. Participants without tumor progression at the time of analysis will be censored at the date of their last tumor assessment. Log-rank test will be applied to test the differences in survivals between levels of prognostic factors.

Kaplan-Meier estimates of progression-free survival will be provided. Progression-free survival will be calculated from the first day of receiving study drug until documented progressive disease or death due to any cause (if death occurs before progression). Log-rank test will be applied to test the differences in survivals between levels of prognostic factors.

The following biomarkers may be measured where appropriate, dependent on sample availability: phosphorylated ERK, phosphorylated VEFGR-2, p53 expression, CD31, CD34 and CD105 expression, HIF-1 alpha, HIF-2 alpha, Glut-1, CAIX, VHL and p53 mutational status, methylation status, blood cell RNA expression profiling, protein pattern profiling, Her-2, VEGF, and VEFGR2 expression. Correlation with clinical outcomes will be attempted. The association among various continuous and discrete variables will be assessed first by the exploratory data analysis using scatter plot matrix, box plots, BLiP plot. Correlation among continuous variables will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete variables will be tested by Chi-square or Fisher's exact test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck	NCT01064479	Metastatic Squa... Metastatic Squa... Metastatic Squa... Metastatic Squa... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Oral C... Stage IV Oropha... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oral ... Stage IVC Oroph...	Carboplatin Cisplatin Docetaxel Erlotinib Hydro... Laboratory Biom... Pharmacological... Placebo Quality-of-Life...	18 Years -	M.D. Anderson Cancer Center
Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck	NCT01064479	Metastatic Squa... Metastatic Squa... Metastatic Squa... Metastatic Squa... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Oral C... Stage IV Oropha... Stage IVA Hypop... Stage IVA Laryn... Stage IVA Oral ... Stage IVA Oroph... Stage IVB Hypop... Stage IVB Laryn... Stage IVB Oral ... Stage IVB Oroph... Stage IVC Hypop... Stage IVC Laryn... Stage IVC Oral ... Stage IVC Oroph...	Carboplatin Cisplatin Docetaxel Erlotinib Hydro... Laboratory Biom... Pharmacological... Placebo Quality-of-Life...	18 Years -	M.D. Anderson Cancer Center
Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer	NCT00494182	Metastatic Head... Metastatic Squa... Metastatic Squa... Metastatic Squa... Metastatic Squa... Recurrent Head ... Recurrent Hypop... Recurrent Laryn... Recurrent Oral ... Recurrent Oroph...	Carboplatin Paclitaxel Sorafenib	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for metastatic squamous cell carcinoma of the oral cavity