Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer

NCT01566435 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201202113
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF) consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site

  * Response will be assessed by laryngoscopy. * CR: disappearance of all lesions

  6 weeks (2 cycles of therapy)

Secondary Outcomes (13)

• Percentage of Participants With Partial Response (PR) at Primary Tumor Site

  6 weeks (2 cycles of therapy)

• Number of Participants Per Anatomic Tumor Response by CT Scan

  6 weeks (2 cycles of therapy)

• Metabolic Tumor Responses as Measured by FDG-PET/CT

  6 weeks (2 cycles of therapy)

• Overall Survival Rate

  2 years

• Adverse Events as Measured by Number of Participants That Experienced Each Common Adverse Event During ACF Induction Therapy

  From start of treatment through 30 days after end of treatment

Study Arms (1)

Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

EXPERIMENTAL

ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks) 1. nab-Paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 2. Cisplatin 75 mg/m\^2 on Day 1 3. 5-FU 750 mg/m\^2 on Days 1-3 If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF. Definitive Therapy 1. Cisplatin 100 mg/m\^2 IV on Days 1, 22, and 43 2. Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions. 3. If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m\^2 IV week for 8 weeks

Drug: paclitaxel albumin-stabilized nanoparticle formulation; Drug: Cisplatin; Drug: Fluorouracil; Radiation: Intensity modulated radiation therapy; Drug: Cetuximab; Procedure: Quality-of-life assessment

Interventions

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Also known as: ABI-007, Abraxane, Albumin-Stabilized Nanoparticle Paclitaxel, nab paclitaxel, nab-paclitaxel, nanoparticle

Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

Cisplatin DRUG

Also known as: CACP, CDDP, CPDD, DDP, Neoplatin

Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

Fluorouracil DRUG

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU, Adrucil, Efudex, FU

Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

Intensity modulated radiation therapy RADIATION

Also known as: IMRT

Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

Cetuximab DRUG

Also known as: Anti-EGFR Monoclonal Antibody, C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

Quality-of-life assessment PROCEDURE

ACF baseline, IMRT baseline, Day 7, Week 12, months 6 and 12

Also known as: FACT H&N, FACT/GOG-NTX-4

Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy

Eligibility Criteria

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

You may qualify if:

• Patient must have selected stage III or IVa/b head and neck squamous cell carcinoma (HNSCC); all patients must have T2-T4 primary tumors; (patients with T1 tumors will be excluded); although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible
• Patient must have disease at the oropharynx, hypopharynx, larynx, or oral cavity sub-sites
• Patient must have measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with CT scan
• Patient must be \>= 18 years of age.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Patient must have adequate bone marrow and organ function as defined below:
• Absolute neutrophil count (ANC) \>= 1500/mcL
• Platelets \> 100,000/mcL
• Hemoglobin \> 9.0 g/dL
• Total bilirubin =\< 1.5 mg/dL
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
• Alkaline phosphatase =\< 2.5 x ULN
• Serum creatinine \< 1.8 mg/dL
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 3 months after completing treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
• Patient must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

You may not qualify if:

• Patient must not have had prior chemotherapy, prior epidermal growth factor receptor (EGFR) targeted therapy, or prior radiation therapy for HNSCC
• Patient must not have a history of prior invasive malignancy diagnosed within 3 years prior to study enrollment other than local stage non-melanoma skin cancer
• Patient must not be receiving any other investigational agents
• Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in this study
• Patient must not be taking cimetidine or allopurinol. If currently taking either of these medications, patient must discontinue for one week before receiving treatment with nab-paclitaxel
• Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or serious psychiatric illness/social situations that would limit compliance with study requirements
• Patient must not be pregnant and/or breastfeeding; a negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential
• Patient must not be known to be human immunodeficiency virus (HIV)-positive on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study agents; in addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
• Patient must not have peripheral neuropathy \> grade 1

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Celgene: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Adkins D, Ley J, Oppelt P, Gay HA, Daly M, Paniello RC, Jackson R, Pipkorn P, Rich J, Zevallos J, Trinkaus K, Thorstad W. Impact on Health-Related Quality of Life of Induction Chemotherapy Compared With Concurrent Cisplatin and Radiation Therapy in Patients With Head and Neck Cancer. Clin Oncol (R Coll Radiol). 2019 Sep;31(9):e123-e131. doi: 10.1016/j.clon.2019.05.007. Epub 2019 May 28.

  PMID: 31147146 DERIVED

• Adkins D, Ley J, Oppelt P, Wildes TM, Gay HA, Daly M, Rich J, Paniello RC, Jackson R, Pipkorn P, Nussenbaum B, Trinkaus K, Thorstad W. nab-Paclitaxel-based induction chemotherapy with or without cetuximab for locally advanced head and neck squamous cell carcinoma. Oral Oncol. 2017 Sep;72:26-31. doi: 10.1016/j.oraloncology.2017.07.001. Epub 2017 Jul 8.

  PMID: 28797458 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Douglas Adkins, M.D.
• Organization: Washington University School of Medicine

dadkins@wustl.edu

314-747-7402

Study Officials

• Douglas Adkins, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: August 9, 2012
• Primary Completion: October 31, 2013
• Study Completion: October 31, 2019
• Last Updated: October 1, 2020
• Results First Posted: December 14, 2015

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)