Status:
UNKNOWN
Dose-finding Study of Weekly Paclitaxel and Cisplatin in FIGO IB2 and Bulky IIA Cervical Cancer
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Sinphar Pharmaceutical Co., Ltd
Conditions:
Cervical Cancer
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
Brief Summary
This phase I study is designed to establish an optimal dose of paclitaxel, under a fixed cisplatin dose at 40 mg/m2, delivered every week for three weeks, as neoadjuvant therapy before radical hystere...
Detailed Description
This is a multi-center, open-label, phase I study of paclitaxel and cisplatin as neoadjuvant therapy in patients with FIGO IB2 or bulky IIA, squamous cell cervical carcinoma of the uterine cervix. Th...
Eligibility Criteria
Inclusion
- women aged 35-70 years with all of the following criteria: untreated, histologically confirmed squamous cell carcinoma of the uterine cervix FIGO stage IB2 or bulky IIA, with tumor extension limited to within the upper one third of the vaginal wall. Bulky tumor is defined as (a) a visible cervical tumor with the largest diameter \>4 cm or (b) a cervix expanded to \> 4 cm as a result of tumor infiltration by pelvic examination and verified by magnetic resonance image (MRI), 3-dimensional (D) computed tomography (CT), or 3-D ultrasound study no suspicious lymph node metastasis as no enlarged lymph node or extrapelvic spread of cancer detected by MRI, or negative cytologic or histologic study of the suspicious node(s) (for those also participating PET-CT monitoring response trial, only abnormal FDG uptake in pelvic node(s) without proven nodal or extrapelvic metastasis are eligible)
Exclusion
- Histological or cytological documented pelvic lymph node or extrapelvic metastasis, concurrent or history of malignant tumor(s) other than treated nonmelanoma skin cancer had undergone surgical procedure other than cervical biopsy or had received cytotoxic procedure including chemotherapy, radiotherapy or treatment with biologic response modifier(s) for the cervical tumor participate in investigational treatment for the cervical cancer history of allergic reaction to platinum or paclitaxel uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements pregnant or breast feeding women, a urinary pregnancy test must be performed on all patients who are of child-bearing potential before entering the study and the result must be negative
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Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00823186
Start Date
February 1 2009
End Date
January 1 2013
Last Update
January 5 2010
Active Locations (3)
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1
Chang Gung Memorial Hospital
Taoyuan District, Lin Kou, Taiwan, 333
2
Chang Gung Memory Hpspital
Chiayi City, Taiwan
3
Taipei Chang Gung Memory Hospital
Taipei, Taiwan