Know Cancer

forgot password

Phase I Trial of ABI-007 (Abraxane) Plus Cisplatin Plus 5-Fluorouracil (APF) as Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Squamous Cell Cancers of the Head and Neck (HNSCC)

Phase 1
18 Years
Open (Enrolling)
Head and Neck Cancer

Thank you

Trial Information

Phase I Trial of ABI-007 (Abraxane) Plus Cisplatin Plus 5-Fluorouracil (APF) as Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Squamous Cell Cancers of the Head and Neck (HNSCC)

Squamous cell carcinoma of the head and neck (HNSCC) is the 9th most common malignancy
diagnosed in Canadians. In the year 2007, there was an estimated 4,350 new cases diagnosed
in Canada, with approximately 1,600 deaths attributable to HNSCC[Canadian Cancer Statistics
2007]. In the United States there is an annual incidence of approximately 40,000 newly
diagnosed cases of head and neck cancer [US Cancer Statistics 2006]. Primary treatment for
newly diagnosed localized (stage I-II) HNSCC is surgery and/or radiotherapy. The majority of
patients (70%) however present with locally advanced HNSCC (Stage III or IV). Treatment of
locally advanced HNSCC generally consists of either concurrent chemotherapy and radiation or
surgical resection followed by adjuvant radiation or adjuvant concurrent chemotherapy and
radiation. Unfortunately despite aggressive treatment with combined modality therapies
approximately 40-50% of cases recur, with the majority recurring at the primary site and/or
regional nodes. Except for a small minority of patients in whom salvage surgery or
radiotherapy can be delivered, the prognosis for the majority of these patients is poor and
further treatment is generally considered palliative.

Inclusion Criteria:

1. 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

2. Non-metastatic, stage III or IV disease (UICC/AJCC classification, 6th edition)

3. Age ≥ 18.

4. ECOG performance status of 0 or 1.

5. Patients must have adequate hematological function:

- absolute granulocyte count > 1.5 x 109/L

- platelet count >100 x 109/L

- hemoglobin > 90 g/L

6. 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

7. Signed written consent.

8. Availability for follow-up for up after treatment.

9. 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.

10. Life expectancy greater than 6 months

Exclusion Criteria:

1. 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.

2. 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.

3. Evidence of distant metastases.

4. Symptomatic peripheral neuropathy ≥ grade 1 by CTCAE v.3 criteria.

5. Clinically significant sensorineural hearing impairment which may be exacerbated by
cisplatin (audiometric abnormalities without corresponding clinical deafness will not
be grounds for exclusion)

6. Weight loss greater than 20% of usual body weight in the 3 months preceding trial

7. High risk for poor compliance with therapy or follow-up as assessed by investigator.

8. Pregnant or lactating women.

9. Prior radiation therapy to greater than 30% of the bone marrow

10. Prior experimental therapy for cancer within 30 days of entering the trial.

11. Prior radiation for head and neck cancer.

12. Prior systemic chemotherapy for cancer.

13. 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

two years

Safety Issue:


Principal Investigator

Lillian Siu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network - Princess Margaret Hospital


Canada: Health Canada

Study ID:




Start Date:

July 2008

Completion Date:

March 2013

Related Keywords:

  • Head and Neck Cancer
  • Abraxane
  • Head and Neck Cancer
  • Determine
  • Maximum
  • Tolerated dose
  • ABI-007
  • Combination
  • Cisplatin
  • 5-Fluorouracil
  • Patients
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms