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Intraperitoneal Aerosol Chemotherapy in Gastric Cancer (PIPAC-GA01)

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ClinicalTrials.gov Identifier: NCT01854255
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum

Brief Summary:
A prospective series of patients with recurrent gastric cancer will be treated with three cycles of chemotherapy (doxorubicin and cisplatin) instilled into the abdominal cavity in the form of an aerosol under pressure via laparoscopy. The efficacy of this treatment will be assessed by computed tomography, tumor marker studies, and survival. Also, the safety of the procedure will be assessed.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: doxorubicin and cisplatin Phase 2

Detailed Description:

Objectives: To evaluate the safety and efficacy in terms of the clinical benefit rate (CBR) of PIPAC in peritoneal carcinomatosis (PC) from gastric cancer (GC) Study design: Single center, open label, non-randomized, single-arm, repeated single dose study to explore the efficacy, safety, and CBR of doxorubicin and cisplatin when given as a pressurized intraperitoneal aerosol chemotherapy (PIPAC) to patients with advanced gastric cancer and peritoneal carcinomatosis.

Target subject population:Patients with GC and PC with disease progression after at least one line of previous i.v. chemotherapy.

Investigational product, dosage and mode of administration 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 4-6 weeks, applied intraperitoneally as PIPAC.

Duration of treatment: 3 single doses in 6 weeks intervals, duration of treatment is 18 weeks

Outcome variables:

1.1 Primary outcome variable • Clinical Benefit Rate (CBR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) after 3 cycles of PIPAC with cisplatin and doxorubicin.

1.2 Secondary outcome variables

  • The observed survival (OS)
  • The median time to progression (TTP) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin
  • The Peritoneal Carcinomatosis Index (PCI) before and after therapy
  • The degree of histological regression assessed by pathological review
  • Apoptosis as assessed by immunohistochemical analysis
  • The difference in ascites volume before and after the first, second, and third PIPAC application 1.3 Patient reported outcomes (PROs)
  • European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30, German version ) 1.4 Safety
  • Safety and tolerability will be assessed by collection of adverse events, according to the Common Terminology Criteria for Adverse Events (CTCAE) including physical examination results, laboratory assessments (chemistry and hematology).

1.5 Biological monitoring

• Basic research investigating expression of genes associated with drug resistance.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Patients With Gastric Cancer and Peritoneal Carcinomatosis: an Open-label, Single-arm, Phase II Clinical Trial
Study Start Date : November 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Intraperitoneal Chemotherapy
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 4-6 weeks, applied intraperitoneally as pressurized aerosol chemotherapy. Duration of treatment will be 3 single doses in 6 weeks intervals, thus the duration of treatment is 18 weeks.
Drug: doxorubicin and cisplatin
doxorubicin and cisplatin as intraperitoneal chemotherapy
Other Names:
  • doxorubicin 50 HEXAL®
  • cisplatin 10 HEXAL®




Primary Outcome Measures :
  1. Clinical Benefit Rate [ Time Frame: within 3 months after treatment completion ]
    Clinical Benefit Rate according to RECIST criteria after 3 cycles of PIPAC with cisplatin and doxorubicin.


Secondary Outcome Measures :
  1. Observed Survival [ Time Frame: During treatment and follow-up of 1 year ]
    Survival will be assessed by direct observation during treatment and by follow-up investigation for 1 year after completion of the study


Other Outcome Measures:
  1. median time ot progression [ Time Frame: during treatment and follow-up of 1 year ]
    Time to progression according to RECIST criteria during treatment and during follow-up of 1 year



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age above 18 years
  • written, informed consent
  • presence of peritoneal carcinomatosis

Exclusion Criteria:

  • language barrier
  • parenchymal metastases
  • unability to undergo laparoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854255


Locations
Germany
Ruhr University of Bochum
Herne, North Rhine Westphalia, Germany, 44625
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Marc A Reymond, MD Ruhr University of Bochum

Responsible Party: Clemens Tempfer, Clemens Tempfer, MD, MBA, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01854255     History of Changes
Other Study ID Numbers: PIPAC-GA01
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by Clemens Tempfer, Ruhr University of Bochum:
Gastric
Cancer
Chemotherapy
Intraperitoneal

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Liposomal doxorubicin
Cisplatin
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action