Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
4 other identifiers
interventional
27
1 country
1
Brief Summary
Phase II trial to study the effectiveness of docetaxel in treating patients who have persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 8, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2006
CompletedJanuary 10, 2018
January 1, 2018
4.4 years
July 8, 2002
January 9, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Duration of progression-free interval
5 years
Frequency and duration of objective response as assessed on radiologic scan
5 years
Frequency and severity of observed adverse effects
5 years
Survival time
5 years
Study Arms (1)
Treatment (docetaxel)
EXPERIMENTALPatients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Histologically confirmed persistent or recurrent squamous cell carcinoma of the cervix
- Progressive disease
- At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Tumors within a previously irradiated field are not considered target lesions
- One prior systemic chemotherapeutic regimen for advanced, metastatic, or recurrent squamous cell carcinoma of the cervix required
- Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen
- Ineligible for a higher priority GOG protocol (e.g., any active Phase III GOG protocol or GOG-0076)
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Agustin Garcia
Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2002
First Posted
January 27, 2003
Study Start
June 1, 2002
Primary Completion
October 23, 2006
Last Updated
January 10, 2018
Record last verified: 2018-01