Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00102375

Enrollment

900

Registered

2005-01-31

Start date

1999-12-31

Completion date

2004-10-31

Last updated

2006-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer, first-line, Topotecan

Brief summary

The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel.

Detailed description

Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good. Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel

Interventions

DRUGTopotecan

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary * International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardless of measurable or non-measurable disease * No prior chemo- or radiotherapy * Adequate hematologic, renal and hepatic function: * ANC ≥ 1.5 x 10\^9/L, * Platelet counts ≥ 100 x 10\^9/L, * Total bilirubin ≤ 1.5 x upper normal limit, * Alkaline Phosphatase ≤ 3 x upper normal limit, * Serum creatinine ≤ 1.25 upper normal limit, * Estimated GFR ≥ 60 ml/min * Performance status 0-2 (ECOG) * Life expectancy must be greater than 12 weeks

Exclusion criteria

* Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mullerian tumors) or tumors of low malignant potential (borderline tumors) * Prior treatment with chemo- or radiotherapy * Administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy * History of congestive heart failure * Symptomatic brain metastasis * Complete bowel obstruction * Dementia * Active infection or other serious underlying medical condition * Pre-existing motor or sensory neurologic pathology

Design outcomes

Primary

Measure	Time frame
Survival	—

Secondary

Measure	Time frame
Progression-free survival	—
Response rate	—
Response duration	—
Toxicities	—
Quality of Life	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026