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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Fluorouracil; Paclitaxel

Criteria

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 eligible.

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 ml/min

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 entry.

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.