Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.


Clinical Trial Description

OBJECTIVES:

- Determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva.

- Determine the objective response rate and duration of response in these patients treated with this drug.

- Determine the acute side effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study. ;


Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00014599
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Completed
Phase Phase 2
Start date February 2001

See also
  Status Clinical Trial Phase
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A
Completed NCT01986725 - The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence Phase 2
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Completed NCT05372016 - Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3
Recruiting NCT05743517 - Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment) N/A
Recruiting NCT05914974 - Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Recruiting NCT05979610 - Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies Phase 2
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Active, not recruiting NCT04357873 - Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Phase 2
Completed NCT00551187 - A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Phase 2
Completed NCT00520598 - Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Phase 2
Terminated NCT00669422 - ChemoFx® PRO - A Post-Market Data Collection Study N/A
Completed NCT03676101 - Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 1
Not yet recruiting NCT06039111 - Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma Phase 2
Recruiting NCT06127836 - Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer N/A
Completed NCT04952961 - Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study N/A
Completed NCT01806350 - Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors N/A
Completed NCT00019110 - Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer Phase 1
Recruiting NCT04141449 - A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation Phase 2