Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer

NCT00851877 | Completed Phase 1 Results

• 3 other identifiers: STU 072010-046SCCC-112008-019CDR0000634258
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; tongue cancer

Outcome Measures

Primary Outcomes (2)

• Phase I Maximum Tolerated Dose of Nab-Paclitaxel

  Seven participants were assigned nab-paclitaxel in dose of 25mg/m\^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m\^2.

  90 days

• Phase II 2-year Progression-free Survival

  Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death.

  2 year

Secondary Outcomes (2)

• Phase II 2-year Local Control

  2 year

• Phase II 2-year Overall Survival

  2 year

Study Arms (1)

arm one

EXPERIMENTAL

Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy

Biological: Cetuximab; Drug: Cisplatin; Drug: Nab-Paclitaxel; Radiation: intensity-modulated radiation therapy

Interventions

Cetuximab BIOLOGICAL

Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor

arm one

Cisplatin DRUG

Cisplatin is an anti-cancer chemotherapy drug

Also known as: Platinol

arm one

Nab-Paclitaxel DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Also known as: Abraxane

arm one

intensity-modulated radiation therapy RADIATION

intensity-modulated radiation therapy

arm one

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx * Diagnosis based on the primary lesion and/or lymph nodes * Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0) * No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands * No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9.0 g/dL (transfusion or other intervention to achieve hemoglobin \> 8.0 g/dL allowed) * Bilirubin ≤ 1.5 mg/dL * AST, ALT, and AP ≤ 2.5 times upper limit of normal * Serum creatinine ≤ 1.5 mg/dL * Creatinine clearance ≥ 50 mL/min * None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0: * Calcium \< 7 mg/dL or \> 12.5 mg/dL * Glucose \< 40 mg/dL or \> 250 mg/dL * Magnesium \< 0.9 mg/dL or \> 3 mg/dL * Potassium \< 3 mmol/L or \> 6 mmol/L * Sodium \< 130 mmol/L or \> 155 mmol/L * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for ≥ 3 years * No prior allergic reaction to study drugs * No active cardiac disease, defined as any of the following: * Unstable angina * Uncontrolled hypertension * Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) * Uncontrolled arrhythmia * Congestive heart failure * Three or more heart-related hospitalizations within the past year * No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year * No AIDS * No pre-existing peripheral sensory neuropathy ≥ grade 2 * No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival PRIOR CONCURRENT THERAPY: * No prior systemic chemotherapy for this cancer * Prior systemic chemotherapy for a different cancer allowed * No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields * No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease) * At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim \[G-CSF\]) during radiotherapy * No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Baylor Research Institute

Dallas, Texas, 75204, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75239, United States

Location

MeSH Terms

Conditions

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

Interventions

Cetuximab; Cisplatin; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Director of Clinical Trial
• Organization: UT Southwestern Medical Center

ClinicalTrials@utsouthwestern.edu

Study Officials

• Hak Choy, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: August 3, 2015
• Last Updated: August 21, 2020
• Results First Posted: August 8, 2018

Record last verified: 2018-07

Locations

US (2)