Chemotherapy with paclitaxel and capecitabine for the treatment of recurrent or metastatic head and neck cancer

Phase II analysis of paclitaxel and capecitabine in the treatment of recurrent or disseminated squamous cell carcinoma of the head and neck region

Registry ID

ISRCTN14555104

Source registry

ISRCTN

Status

No longer recruiting

Phase

PHASE2

Study type

INTERVENTIONAL

Sponsor

Department of Oncology, Herlev Hospital

Enrollment

183

Start date

2000-09-01

Completion date

2008-12-31

Last update

2026-08-17

Conditions

• Cancer
• Squamous cell carcinoma of the head and neck

Summary

Recurrent or disseminated squamous cell carcinoma of the head and neck

Detailed description

The treatment plan was as follows: Day 1: Paclitaxel 175 mg/m2 iv over 3 h Days 1 to 14: Capecitabine 825 mg/m2 per dose orally bid (twice daily) for 2 weeks, with 200 ml water taken <30 min after a meal After a 1-week interval without medication, the treatment was repeated. The patients received the following iv premedication 30 min before administration of paclitaxel: dexamethasone 10 mg, clemastine 2 mg, and nizatidine 100 mg.

Interventions

• DRUG: The treatment plan was as follows: Day 1: Paclitaxel 175 mg/m2 iv over 3 h Days 1 to 14: Capecitabine 825 mg/m2 per dose orally bid (twice daily) for 2 weeks, with 200 ml water taken <30 min after a meal After a 1-week interval without medication, the treatment was repeated. The patients received the following iv premedication 30 min before administration of paclitaxel: dexamethasone 10 mg, clemastine 2 mg, and nizatidine 100 mg.

Inclusion criteria

1. Histologically confirmed recurrent or disseminated squamous cell carcinoma of the head and neck region, not suitable for curative radiotherapy or salvage surgery 2. Measurable disease in minimum 2 dimensions 3. Aged 18-75 years 4. World Health Organization (WHO) performance status <=2 5. No previous chemotherapy for 1 month 6. No other severe life-shortening disease or other malignant disease 7. Adequate bone marrow, liver, and renal function

Exclusion criteria

1. Non-measurable disease 2. Pregnant or breastfeeding women 3. Chemotherapy within the last month 4. Brain metastases 5. Other malignant disease

Locations

• , , Denmark

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