Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Topotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days

HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1

topotecan

CARBOPLATIN

GSK Clinical Trials

This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.

Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer

Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization \[WHO\] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: \>50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: \>25% increase in measurements of lesions or appearance of new lesions).

Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; \>50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions).

Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored".

Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored". Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "PFS". As such, "PFS" was measured, not "Time to Disease Progression".

The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was "censored".

CA-125 is a "tumor marker", found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline.

Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "Progression-free Survival". As such, "Progression-free Survival" was measured, not "Time to Disease Progression". See the outcome measure entitled "Progression-free Survival" for data pertaining to time to disease progression.

GlaxoSmithKline

Adverse events that were rounded up to 5% in the CSR (e.g. 1/22; 4.54%) are also included here.

Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)

Dose-finding Phase

Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.

Activity Assessment Phase

Total

Age Continuous

Sex: Female, Male

African American/African Heritage

American Indian or Alaska Native

Asian

White

Missing

Race/Ethnicity, Customized

Grade 0

Grade 1

Grade 2

Eastern Cooperative Oncology Group (ECOG) performance status assesses the effect of disease on daily living abilities, graded as: Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity; Grade 2: Capable of all selfcare, but unable to carry out any work activities.

Number of participants with the indicated ECOG Performance Status

As only 17 of 55 participants had CR/PR, the treatment was not effective. The follow up of participants for survival was thus stopped early (original plan: every 3 months for 2 years; then every 6 months for 3-5 years; then annually/until death).

GSK Response Center

All participants who showed a tumor response (CR or PR).

Time to Response

Duration of Response

Complete response

Partial response

Stable disease

Progressive disease

Not evaluable

Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug

Number of Participants With the Indicated Response

Progression-free Survival

Died

Censored

Number of Participants Who Died From the Start of Treatment to Follow-up

The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)

Time to Disease Progression

Run-in Phase

Treatment Phase

Spots Global Cancer Trial Database for Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial