A Phase I Trial of Abraxane, Cisplatin and 5-Fluorouracil Along With Chemoradiotherapy in Advanced Head and Neck Cancer

NCT00731380 | Completed Phase 1

• 1 other identifier: APF-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the highest dose of a ABI-007 that can be given with cisplatin and 5-fluorouracil without causing intolerable side effects in patients with advanced head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

Abraxane; Head and Neck Cancer; Determine; Maximum; Tolerated dose; ABI-007; Combination; Cisplatin; 5-Fluorouracil; Patients

Outcome Measures

Primary Outcomes (1)

• The maximum tolerated dose of ABI-007 with Cisplatin and 5-Fluorouracil (APF)

  two years

Secondary Outcomes (1)

• safety and tolerability profiles for ABI-007

  two years

Study Arms (1)

ABI-007 escalation; then radiation + AUC

EXPERIMENTAL

Dose escalation beginning with ABI-007 75 mg/m2 day 1 + day 8, Cisplatin 100 mg/m2 day 1, 5-FU 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, for 3 weeks x 3 cycles. Followed by Concurrent weekly Carboplatin (AUC 1.5) with radiotherapy for 7 weeks. Carboplatin should be given on Monday or Tuesday of each week, if possible.

Drug: ABI-007

Interventions

ABI-007 DRUG

Dose escalation beginning with ABI-007 75 mg/m2 day 1 + day 8, Cisplatin 100 mg/m2 day 1, 5-Fluorouracil (5-FU) 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, for 3 weeks x 3 cycles. Followed by Concurrent weekly Carboplatin (AUC 1.5) with radiotherapy for 7 weeks. Carboplatin should be given on Monday or Tuesday of each week, if possible.

Also known as: Abraxane

ABI-007 escalation; then radiation + AUC

Eligibility Criteria

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

You may qualify if:

• Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Histological or cytological confirmation is required. The disease must be considered to be potentially curable by combined chemoradiation. Patients with nasopharynx, paranasal sinus, skin or unknown primary sites are not eligible.
• Non-metastatic, stage III or IV disease (UICC/AJCC classification, 6th edition)
• Age ≥ 18.
• ECOG performance status of 0 or 1.
• Patients must have adequate hematological function:
• absolute granulocyte count \> 1.5 x 109/L
• platelet count \>100 x 109/L
• hemoglobin \> 90 g/L
• Must have adequate renal and hepatic function:
• serum bilirubin \< 1.5x UNL and AST/ALT \<2.5x UNL
• serum creatinine \< 1.25 x UNL or a calculated creatinine clearance of \> 60 ml/min
• Signed written consent.
• Availability for follow-up for up after treatment.
• The patient is fertile and is aware of the risk of becoming pregnant or fathering children and will use adequate contraception (oral contraception, IUD, diaphragm and spermicide or male condom and spermicide) throughout therapy and for at least 3 months after therapy.
• Life expectancy greater than 6 months

You may not qualify if:

• Significant inter-current illness that will interfere with the chemotherapy or radiation therapy during the trial such as HIV infection, cardiac insufficiency, pulmonary compromise, active significant alcohol abuse, uncontrolled psychotic disorder, active infection or febrile illness.
• Any history of myocardial infarction, any history of ventricular arrhythmias, angina or active coronary heart disease within 6 months. Significant cardiac disease resulting in an inability to tolerate the intravenous fluid load as required for administration of cisplatin.
• Evidence of distant metastases.
• Symptomatic peripheral neuropathy ≥ grade 1 by CTCAE v.3 criteria.
• Weight loss greater than 20% of usual body weight in the 3 months preceding trial entry.
• High risk for poor compliance with therapy or follow-up as assessed by investigator.
• Pregnant or lactating women.
• Prior radiation therapy to greater than 30% of the bone marrow
• Prior experimental therapy for cancer within 30 days of entering the trial.
• Prior radiation for head and neck cancer.
• Prior systemic chemotherapy for cancer.
• Patients with prior cancers, except: those diagnosed more than five years ago with no evidence of disease recurrence and a clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix. However, any patient with previous invasive breast cancer, prostate cancer or melanoma is excluded.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Celgene Corporation: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 3M9, Canada

Location

Related Publications (1)

• Loong HH, Winquist E, Waldron J, Chen EX, Kim J, Palma D, Read N, Razak AR, Diaz-Padilla I, Chan K, Bayley A, Hossain M, Wang L, Chin S, Siu LL, Hope A. Phase 1 study of nab-paclitaxel, cisplatin and 5-fluorouracil as induction chemotherapy followed by concurrent chemoradiotherapy in locoregionally advanced squamous cell carcinoma of the oropharynx. Eur J Cancer. 2014 Sep;50(13):2263-70. doi: 10.1016/j.ejca.2014.05.021. Epub 2014 Jun 19.

  PMID: 24953566 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Lillian Siu, MD

  University Health Network - Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

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: August 6, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

CA (1)