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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01566435
First received: March 27, 2012
Last updated: November 17, 2014
Last verified: November 2014

March 27, 2012
November 17, 2014
August 2012
October 2013   (final data collection date for primary outcome measure)
CR by clinical exam at primary tumor site [ Time Frame: 6 weeks (2 cycles of therapy) ] [ Designated as safety issue: No ]
Response will be assessed by laryngoscopy.
CR by clinical exam at primary tumor site after two cycles of ACF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Response will be assessed by laryngoscopy.
Complete list of historical versions of study NCT01566435 on ClinicalTrials.gov Archive Site
  • Comparison of CR at primary tumor site after ACF to historical CR [ Time Frame: 6 weeks (2 cycles of therapy) ] [ Designated as safety issue: No ]
    A one-sample test for noninferiority will be used.
  • PR at primary tumor site and CR or PR at regional nodes [ Time Frame: 6 weeks (2 cycles of therapy) ] [ Designated as safety issue: No ]
    Response will be assessed by laryngoscopy.
  • Anatomic tumor response by CT scan [ Time Frame: 6 weeks (2 cycles of therapy) ] [ Designated as safety issue: No ]
    Response assessed using RECIST criteria version 1.0
  • Metabolic tumor response by FDG-PET/CT [ Time Frame: 6 weeks (2 cycles of therapy) ] [ Designated as safety issue: No ]
    Response assessed using RECIST criteria version 1.0
  • Survival (OS, DFS and PFS) as a measure of response to ACF in patient population [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Kaplan-Meier models will be used to estimate median (if the median is reached) and to estimate 1 and 2 year rates with 95% confidence intervals.
  • Document and grade adverse events (AE's) with ACF [ Time Frame: From start of treatment through 30 days after end of treatment ] [ Designated as safety issue: Yes ]
    Type and grade of toxicity assessed by NCI-CTCAE version 3; Compare AE rates with ACF to those with ACCF (historical data).
  • Changes in SPARC and Ki-67 expression [ Time Frame: 6 weeks (2 cycles of therapy) ] [ Designated as safety issue: No ]
    Primary tumor biopsy; analyzed using IHC.
  • Quality of life [ Time Frame: Through one year after completion of treatment ] [ Designated as safety issue: No ]
    Assessed using questionnaires administered at 6 time points starting at baseline.
  • Comparison of CR at primary tumor site after ACF to historical CR after ACCF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    A one-sample test for noninferiority will be used.
  • PR at primary tumor site and CR or PR at regional nodes after two cycles of ACF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Response will be assessed by laryngoscopy.
  • Anatomic tumor response by CT scan after two cycles of ACF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Response assessed using RECIST criteria version 1.0
  • Metabolic tumor response by FDG-PET/CT after two cycles of ACF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Response assessed using RECIST criteria version 1.0
  • Survival (OS, DFS and PFS) as a measure of response to ACF in patient population [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Kaplan-Meier models will be used to estimate median (if the median is reached) and to estimate 1 and 2 year rates with 95% confidence intervals.
  • Document and grade adverse events (AE's) with ACF [ Time Frame: 5 months (during ACF and definitive therapy to 30 days after end of treatment) ] [ Designated as safety issue: Yes ]
    Type and grade of toxicity assessed by NCI-CTCAE version 3; Compare AE rates with ACF to those with ACCF (historical data).
  • Changes in SPARC and Ki-67 expression [ Time Frame: 2 days (at baseline and Week 6) ] [ Designated as safety issue: No ]
    Primary tumor biopsy; analyzed using IHC.
  • Quality of life [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Assessed using questionnaires administered at 6 time points starting at baseline.
Not Provided
Not Provided
 
Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer
Phase II Trial of Nab-Paclitaxel, Cisplatin, and 5-FU (ACF) as Induction Therapy Followed by Definitive Concurrent Chemoradiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Neoplasms
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
    Other Names:
    • ABI-007
    • Abraxane
    • Albumin-Stabilized Nanoparticle Paclitaxel
    • nab paclitaxel
    • nab-paclitaxel, nanoparticle
  • Drug: Cisplatin
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
    • Neoplatin
  • Drug: Fluorouracil
    Other Name: 5-fluorouracil, 5-Fluracil, 5-FU, Adrucil, Efudex, FU
  • Radiation: Intensity modulated radiation therapy
    Other Name: IMRT
  • Drug: Cetuximab
    Other Name: Anti-EGFR Monoclonal Antibody, C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225
  • Procedure: Quality-of-life assessment
    ACF baseline, IMRT baseline, Day 7, Week 12, months 6 and 12
    Other Names:
    • FACT H&N
    • FACT/GOG-NTX-4
Experimental: Arm 1

ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)

  1. nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15
  2. Cisplatin 75 mg/m2 on Day 1
  3. 5-FU 750 mg/m2 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/m2 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/m2 IV week for 8 weeks
Interventions:
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Drug: Cisplatin
  • Drug: Fluorouracil
  • Radiation: Intensity modulated radiation therapy
  • Drug: Cetuximab
  • Procedure: Quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
29
October 2023
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Patient with uncontrolled diabetes or fasting blood glucose level of greater than 200 mg/dL will be eligible for enrollment but will not be evaluable for PET imaging

Exclusion Criteria:

  • 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 disease at the nasopharyngeal, sinus, or other sub-site not specified in the inclusion criteria; patient must not have unknown primary squamous cell carcinoma of the head and neck
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01566435
201202113
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Douglas Adkins, M.D. Washington University School of Medicine
Washington University School of Medicine
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP