Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Topotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

topotecan

GSK Clinical Trials

The purpose of this study is to find out if Hycamtin given weekly is safe and effective for treating your endometrial cancer.

Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

An Open-label, Phase II, Multicenter Study of Intravenous Weekly Topotecan in Subjects With Recurrent or Persistent Endometrial Cancer

Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions

Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.

Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.

The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.

The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.

AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.

GlaxoSmithKline

Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.

Topotecan Hydrochloride

Age Continuous

Sex: Female, Male

Caucasian

African Heritage/African American

Race/Ethnicity, Customized

As there was only 1 responder, time to response, and duration of response were not calculated.

GSK Response Center

Complete Response

Partial Response

Stable Disease

Progressive Disease

Unknown

Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.

Best Overall Response

25th percentile

Median percentile

75th percentile

Time to Progression

Overall Survival

Response Duration

Time to Response

AE: Fatigue

AE: Nausea

AE: Constipation

AE: Abdominal Pain

AE: Vomiting

AE: Hypokalemia

AE: Anorexia

AE: Dyspnea

AE: Diarrhea

AE: Dizziness

AE: Headache

AE: Insomnia

SAE: Abdominal Pain

SAE: Gastrointestinal hemorrhage

SAE: Intestinal obstruction

SAE: Rectal Hemorrhage

SAE: Vomiting

SAE: Pulmonary Embolism

SAE: Dyspnea

SAE: Bacteremia

SAE: Streptococcal Bacteremia

SAE: Cerebral ischemia

SAE: Cerebral infarction

SAE: Incisional hernia, obstructive

SAE: Dehydration

SAE: Embolism venous

Alive at last contact-when follow-up ended

Deaths - any subject

Cause of Death - Disease of Study

Cause of Death - Non-Hematological toxicity

Cause of Death - Other-Brain Metastases

Safety and Tolerability as Summarized Through Adverse Event Reporting

Overall Study

Spots Global Cancer Trial Database for Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial