Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Cisplatin, and Cetuximab Given Together With Radiation Therapy in Treating Patients With Locally Advanced Stage III or Stage IV Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00851877
First received: February 25, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Biological: cetuximab
Drug: cisplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation

  • disease-free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation


Secondary Outcome Measures:
  • Dose-limiting toxicities [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
    Dose-limiting toxicities as assessed by NCI CTCAE v3.0

  • Safety and tolerability [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
    Safety and tolerability

  • Progression-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Progression-free survival

  • Response rates [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Response rates by tumor measurement

  • Overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Overall survival


Estimated Enrollment: 80
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm one
Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Cisplatin, Cetuximab, RT
Biological: cetuximab
cetuximab infusion
Drug: cisplatin
cisplatin
Drug: paclitaxel albumin-stabilized nanoparticle formulation
paclitaxel albumin-stabilized nanoparticle formulation
Radiation: 3-dimensional conformal radiation therapy
3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
intensity-modulated radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)
  • To evaluate the disease-free survival of patients treated with this regimen. (Phase II)

Secondary

  • To identify dose-limiting toxicities in these patients treated with this regimen. (Phase I)
  • To assess the safety and tolerability of this regimen. (Phases I and II)
  • To assess progression-free survival and survival of patients treated with this regimen. (Phase I)
  • To assess overall survival in patients treated with this regimen. (Phase II)
  • To assess response rates in patients treated with this regimen. (Phases I and II)

OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by a phase II study.

Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D conformal or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851877

Locations
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75204
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75239
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Hak Choy, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00851877     History of Changes
Other Study ID Numbers: CDR0000634258, SCCC-112008-019, ABX 236-HN08US
Study First Received: February 25, 2009
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Cisplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014