A Study With Intraperitoneal Cisplatin and Doxorubicin in Recurrent Ovarian Cancer and Peritoneal Carcinomatosis
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Fifteen women with recurrent ovarian cancer will be treated by an intraperitoneal
      chemotherapy with cisplatin and doxorubicin in three escalating dosage schedules. The aim of
      the study is to evaluate the safety and tolerability of doxorubicin and cisplatin every 4
      weeks for three courses using a three-group, dose-escalation protocol with fixed
      dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks.
      Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria. The study
      hypothesis is that local and systemic toxicity will increase with increasing dosage of
      cisplatin and doxorubicin during three repeated PIPAC courses with no CTCAE grade 4 and 5
      events in any treatment group.
    

Detailed description: 
      This is a prospective phase I, single-arm (nonrandomized), open-label, three step
      dose-escalation study with cisplatin and doxorubicin applied as PIPAC in 15 patients with
      recurrent ovarian cancer and peritoneal cancer.

      The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and
      cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will
      receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in
      50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3
      mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for
      three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will
      not be changed.

      The aim of this study is to evaluate the safety and tolerability of doxorubicin and cisplatin
      every 4-6 weeks for three courses using a three-group, dose-escalation protocol with fixed
      dose-density. The time Frame for the assessment of the Primary outcome is therefore 12 weeks.
      Predefined toxicity criteria will be applied using CTCAE version 4.0 criteria, documented
      after the first, second, and third course of treatment. Clinical examinations will include
      abdominal computed tomography (CT) scans after the first, second, and third course of
      treatment, cardiac echocardiography before the first, second, and third course of treatment,
      and a clinical neurological assessment before the first, second, and third course of
      treatment. Pharmacological studies will include hematologic, liver, and renal function tests
      as well as cisplatin and doxorubicin plasma levels with blood samples drawn before, during,
      and up to 12 h after the start of each PIPAC course.
    

Intervention name(s): Cisplatin and doxorubicin; Cisplatin and doxorubicin
Intervention type(s): Drug; Procedure
Intervention description(s): The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will not be changed.; intraperitoneal chemotherapy with cisplatin and doxorubicin in a dose-escalation scheme
Other intervention name(s): Cisplatin TEVA, Doxorubicin 50 HEXAL®; Intraperitoneal chemotherapy
Intervention MeSH terms: Cisplatin; Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian cancer; recurrent; chemotherapy; intraperitoneal; cisplatin; doxorubicin