Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01847326
Other study ID # 12-1554
Secondary ID NCI-2012-02179
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 26, 2013
Est. completion date November 4, 2027

Study information

Verified date January 2024
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by chemoradiation therapy may be an effective treatment for head and neck cancer.


Description:

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) when given in combination with FHX (5 fluorouracil [fluorouracil], hydroxyurea and twice daily radiation, in good induction responders) and of nab-paclitaxel added to hypofractionated radiotherapy for poor responders. II. To explore the feasibility of a more rapid palliative chemoradiotherapy approach inpatients with refractory disease as demonstrated by failure to respond to initial chemotherapy. III. To explore the role of induction chemotherapy as a predictive tool for definitive head and neck cancer management of previously treated patients. SECONDARY OBJECTIVES: I. Progression-free survival (PFS) (time to disease progression or death from any cause) on both study arms. II. Overall survival and response rates in both arms. TERTIARY OBJECTIVES: I. To determine the correlation of secreted protein, acidic, cysteine-rich (SPARC) expression in head and neck cancer and response to therapy. OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation. RE-INDUCTION THERAPY (WEEKS 1-6): Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving good response undergo surgical resection and proceed to chemoradiation within 4-6 weeks. AFHX REGIMEN: Patients achieving response to re-induction therapy receive hydroxyurea orally (PO) every 12 hours for 6 days (11 doses) beginning on day 0, fluorouracil IV continuously over 120 hours beginning on day 0, and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Patients also undergo radiation therapy twice daily (BID) on days 1-5. Courses repeat every 14 days for 5 weeks in the absence of disease progression or unacceptable toxicity. PACLITAXEL + RADIATION (AXX) REGIMEN: Patients not achieving response to re-induction therapy receive paclitaxel albumin-stabilized nanoparticle formulation IV and undergo hypofractionated radiation therapy on day 1. Courses repeat every 7 days for 5 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 2 years, every 6 months for 2 years, and then yearly thereafter.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date November 4, 2027
Est. primary completion date November 4, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy - Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease - Prior radiation therapy completed >= 4 months, and/or chemotherapy completed >= 1 month before study entry, and patient should have recovered from any adverse effects - Predominance of disease that is amenable to radiotherapy - Measurable disease prior to induction chemotherapy - Eastern Cooperative Oncology Group performance status of one or less - Life expectancy of greater than 12 weeks - Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment - Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential - Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE]) - Leukocyte >= 3,000/ul - Absolute neutrophil count >= 1,500/ul - Platelets >= 1000,000/ul - Total bilirubin =< 1.5 x institutional upper limit of normal - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal - Creatinine clearance (CrCl) > 45 mL/min Exclusion Criteria: - Previously untreated patients with locoregional-only disease are not eligible - Patients who have had chemotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients may not be receiving any other investigational agents - History of allergic reactions attributed to compounds of similar chemical composition agents used in the study - Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function - Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
carboplatin
Given IV
paclitaxel albumin-stabilized nanoparticle formulation
Given IV
fluorouracil
Given IV
hydroxyurea
Given PO
Procedure:
therapeutic conventional surgery
Undergo surgical resection
Radiation:
radiation therapy
Undergo radiation therapy
hyperfractionated radiation therapy
Undergo hyperfractionated radiation therapy
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States University of Chicago Comprehensive Cancer Center Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with fluorouracil, hydroxyurea, and radiation therapy, determined according to incidence of DLT graded using the National Cancer Institute (NCI) CTCAE 4.0 4 weeks
Primary Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with radiation therapy, determined according to incidence of DLT graded using the NCI CTCAE 4.0 4 weeks
Secondary PFS Statistical significance will be determined by a two-sided P value =< 0.05. Progression-free survival curves will be calculated using the Kaplan-Meier method, and median progression-free survival time, along with 90% confidence intervals will be derived using the procedure described in Brookmeyer and Crowley. The time from the date of registration to the date of progressive disease or death, assessed up to 1 year
Secondary Overall survival Statistical significance will be determined by a two-sided P value =< 0.05. Overall survival curves will be calculated using the Kaplan-Meier method, and median overall survival time, along with 90% confidence intervals will be derived using the procedure described in Brookmeyer and Crowley. The time from the date of registration to the date of death, assessed up to 1 year
Secondary Objective response rate (complete response [CR] + partial response [PR]) The objective response rate (CR + PR) and associated 90% confidence interval will be determined. Up to 1 year
See also
  Status Clinical Trial Phase
Completed NCT01469429 - Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer. Phase 1/Phase 2
Withdrawn NCT04041141 - Oral Stent Device for Radiation Treatments of Oral Cancers
Completed NCT00049283 - Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer Phase 1
Completed NCT00407810 - Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00096512 - S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT01637194 - Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer Phase 1
Completed NCT00033618 - Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck Phase 2
Completed NCT01816841 - Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care N/A
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Completed NCT04059861 - Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin N/A
Recruiting NCT01854021 - Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer N/A
Withdrawn NCT01674374 - Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy Phase 2
Completed NCT01816984 - PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 1/Phase 2
Terminated NCT01528137 - Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer Phase 1
Completed NCT04337853 - Radiotherapy of Tongue Cancer Using an Intraoral Stent Phase 1
Completed NCT01806675 - 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy Phase 1/Phase 2
Terminated NCT02177838 - Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer N/A
Completed NCT00114283 - Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Phase 2
Completed NCT04126226 - Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy N/A
Completed NCT00293462 - GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer Phase 3