A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix

Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0

时间窗: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event).