Safety and Pharmacokinetics of Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) With Cisplatin to Treat Platinum-sensitive Recurrent Ovarian Cancer

NCT01387399 | Unknown Phase 1 DMC

• 1 other identifier: EudraCT No.: 2010-024652-28
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase I study is to determine the safety, feasibility, maximum tolerated dose (MTD), pharmacokinetics and pharmacodynamics of Cisplatin administered as Intraoperative Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients with Platinum-Sensitive Recurrent Ovarian Cancer.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; recurrence; platinum-sensitive recurrent ovarian cancer; HIPEC; intraperitoneal chemotherapy; hyperthermic intraperitoneal chemoperfusion; cisplatin

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  To determine the safety and maximum tolerated dose (MTD) of cisplatin (60 mg/m², 80mg/m² and 100 mg/m²) administered as intraperitoneal hyperthermic chemoperfusion defined by the dose-limiting toxicity (DLT).

  within the first 21days after surgery

Secondary Outcomes (2)

• Pharmacokinetics

  within 24 hours of HIPEC

• Number of cycles of standard intravenous platinum-based systemic chemotherapy

  3 months

Study Arms (1)

Cisplatin as HIPEC

EXPERIMENTAL

Phase I dose escalating study of cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion

Procedure: Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion

Interventions

Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion PROCEDURE

Classical "3+3" dose escalation study of cisplatin administered as HIPEC (60mg/m², 80mg/m² and 100mg/m²)

Cisplatin as HIPEC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• only female participants are being studied
• signed informed consent
• patients with histologically proven or suspicious recurrent epithelial ovarian cancer (based on Response Evaluation Criteria in Solid Tumors (RECIST)- or CA-125 criteria)
• Progression-free interval after completion of adjuvant platinum-based chemotherapy of 6 months or more.
• Subjects with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma N.O.S.
• Patients are eligible if the disease is deemed operable to equal or less than 1 cm at the completion of surgery.

You may not qualify if:

• mucinous Ovarian cancer
• non-invasive Borderline tumor
• subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin are permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease
• subjects with active infection that requires parenteral antibiotics
• patients with any underlying cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions, chronic or latent infectious diseases, immune deficiency, or history, which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study
• patients with known platinum allergy
• evidence of extensive intraperitoneal adhesions at the time of surgery, as determined by the operating surgeon

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital

Bonn, 53127, Germany

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oliver Zivanovic, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv. Doz. Dr. med. Oliver Zivanovic

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: July 4, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

DE (1)