Phase I study to optimize the safe starting dose of weekly paclitaxel

Phase I study to optimize the safe starting dose of weekly paclitaxel - Optimizing the starting dose of paclitaxel

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020357

Enrollment

Registered

2016-01-04

Start date

2012-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer

Interventions

Administration of Paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility criteria included histologically or cytologically proven head and neck carcinoma with recurrent or metastatic disease; age 20 years or older but less than 75; measurable lesions; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2; adequate organ function, as defined by an absolute neutrophil count (ANC) >2,000, white blood cell count 4,000, platelet count >100,000, hemoglobin >9.0 g/dL, transaminase levels less than 2.5 times the upper limits of normal, ALP, total bilirubin, and serum creatinine less than 1.5 times the upper limits of normal; and life expectancy >3 months from the beginning of treatment. Patients were excluded if they had received three or more prior regimens of chemotherapy for recurrent or metastatic head and neck cancers.

Exclusion criteria

Exclusion criteria: Patients with severe co-morbidity are excluded

Design outcomes

Primary

Measure	Time frame
Starting dose to determine the individualized maximum repeatable dose	—

Countries

Japan

Contacts

Public ContactNaohiro Wakisaka

Kanazawa University Hospital

jibiinfo@med.kanazawa-u.ac.jp076-265-2413

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026