A Phase I/II Study of Pazopanib and Weekly Topotecan in Patients With Platinum-resistant or Intermediate-sensitive Recurrent Ovarian Cancer

NCT01600573 Phase 1/Phase 2 UNKNOWN

This clinical trial shall clarify the efficacy and safety of pazopanib in combination with weekly topotecan in patients with platinum-resistant or intermediate platinum-sensitive recurrent epithelial ovarian cancer, fallopian and peritoneal carcinoma

Details

Lead sponsor	JSehouli
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	68
Start date	2012-05
Completion	2017-03

Conditions

• Ovarian Cancer

Interventions

• pazopanib in combination with weekly topotecan

Primary outcomes

• Phase I: Assessment of dose-limiting toxicity in order to determine the maximum tolerated dose (MTD) of pazopanib in combination with weekly topotecan — after 4 weeks
  Dose-limiting toxicities are defined as follows: * grade 3 or 4 non-hematologic toxicity other than nausea or vomiting * grade 3 or 4 thrombocytopenia (platelet count less than 50000/µl) * grade 4 neutropenia lasting ≥ 7 days or febrile neutropenia defined as ANC \<1000/µl concurrent with fever * Any grade 2 and more toxicity of cycle 1 other than nausea, vomiting, rash, alopecia or anemia, that persisted over 35 days.
• • Phase II: Progression-free survival according to RECIST criteria — up to 3.5 years
  • Phase II: Progression-free survival according to RECIST criteria

Countries

Germany