Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00322920
Eligibility Criteria:
Inclusion Criteria:
* Patients must have persistent, recurrent, or primary Stage IVB carcinoma of the cervix not amenable to curative therapy with either surgery and/or radiation.
* Patients must have biopsy proven squamous cell, adenosquamous, or adenocarcinoma histology.
* Patients do not require measurable disease.
* Patients must have adequate organ function defined by laboratory work.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Patients must have recovered from any effects attributable to surgery, radiation, or chemoradiotherapy. A minimum of six weeks shall have passed since the last administration of chemoradiotherapy or three weeks for radiation therapy alone.
* Patients must be free of clinically significant infections.
* Patients must be age 19 or greater and have signed informed consent.
Exclusion Criteria:
* Patients who are pregnant or lactating.
* Patients with history of other malignancies (except non-melanoma skin cancer) within the last 5 years are ineligible.
* Patients with non-squamous, adenosquamous, or adenocarcinoma histology.
* Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage.
* Patients currently receiving any or having received other investigational agents within the last 30 days are ineligible.
* Patients with known hypersensitivity to topotecan or cisplatin.
* Patients with craniospinal metastases.
* Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT00322920
Study Brief:
Protocol Section:
NCT00322920