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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Principal Investigator

Jacobus Pfisterer, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

AGO Study Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AGO-OVAR 7

NCT ID:

NCT00102375

Start Date:

December 1999

Completion Date:

October 2004

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • first-line
  • Topotecan
  • Ovarian Neoplasms

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