Recurrent/metastatic head and neck squamous cell carcinoma Cancer
Conditions
Interventions
Phase I:
Irinotecan was supplied with the dose of 40, 50, 60, 70 mg/m2, then escalated with 5 mg/m2 increase in each step. Three participants were enrolled in each dose level until the
Sponsors
Taipei Veterans General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 20 and 75 years 2. Histologically or cytologically confirmed non-nasopharyneal head and neck squamous-cell carcinoma which is locoregional recurrence after curative local treatment and unsuitable for further local treatment, or primary distant metastasis at diagnosis, or metastatic disease after primary local treatment. 3. No prior primary chemotherapy for metastatic disease 4. Previous induction or concurrent chemotherapy with primary radiotherapy or adjuvant therapy after curative surgery is allowed, but the chemotherapy regimen has to have been completed at least 3 months before study entry. 5. At least one measurable disease was required, which is defined as lesion that can be measured in at least 1 dimension as ? 20 mm with conventional technique or ? 10 mm with spiral CT scan or MRI. 6. Patients should have life expectancy of at least 12 weeks
Exclusion criteria
Exclusion criteria: 1. Less than 4 weeks since previous radiotherapy or 2 weeks since previous major surgery 2. Presence of CNS metastasis 3. Bone only metastasis 4. Co-existence with other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study 5. Inadequate hematologic function (hemoglobin 1.5 times the upper limit (ULN) or alanine aminotransferase or aspartate aminotransferase > 2.5 times ULN if no liver metastasis or greater than 5 times the normal) 7. Inadequate renal function (serum creatinine > 1.5 mg/dl and creatinine clearance less than 60 ml/min); concurrent treatment with other investigational drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: The determination of a recommended dose of irinotecan when combined with cisplatin and UFUR in patients with recurrent or metastatic HNSCC, by monitoring the dose-limiting toxicity at each dose level. Phase II: Overall objective response rate (ORR) of irinotecan in combination with cisplatin and UFUR. Measurable disease was required, which is defined as a lesion that can be measured in at least 1 dimension as ? 20 mm with conventional technique or ? 10 mm with spiral CT scan or MRI. Tumor assessments were made by computed tomography or magnetic resonance imaging scans at enrollment and after every 3 months until disease progression or withdraw. The revised RECIST guideline (version 1.1) was used to evaluate tumor response. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS) 2. Disease control rate (DCR) 3. Overall survival (OS) 4. Quality of life (QoL) 5. Safety profile | — |
Countries
Taiwan
Outcome results
None listed