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Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy (HIPEC/IPHC)

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ClinicalTrials.gov Identifier: NCT02349958
Recruitment Status : Recruiting
First Posted : January 29, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bay Area Gynecology Oncology

Brief Summary:

To determine treatment response to surgical debulking and intra-operative Intraperitoneal Hyperthermic Chemotherapy (IPHC) in patients with the following malignancies:

Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical cancers).

Mesotheliomas. GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon, appendix).

To monitor the toxicities and complications of this treatment regimen. To measure treatment related QOL changes after IPHC.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Uterine Cancer Mesotheliomas Gastrointestinal Cancers Cervical Cancer Device: HIPEC: MMC 30mg @ T0, 10mg @ T45min Device: HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0 Device: HIPEC: CDDP 75 mg/m2 @T0 Device: HIPEC: CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Using Cisplatin, Mitomycin, and Adriamycin in Peritoneal Surface Malignancies Also Known as Hyperthermic Intraperitoneal Chemotherapy.
Study Start Date : September 2006
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Ovarian peritoneal
CDDP Cisplatin 75 mg/m2 @T0 Ovarian peritoneal fallopian tube Uterine
Device: HIPEC: CDDP 75 mg/m2 @T0
Ovarian/peritoneal/fallopian tube, Uterine CDDP 75 mg/m2 @T0

Appendix Psuedomyxoma
MMC Mitomycin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0 Appendix Psuedomyxoma colorectal small bowel
Device: HIPEC: MMC 30mg @ T0, 10mg @ T45min
MMC 30mg @ T0, 10mg @ T45min for Appendix, Psuedomyxoma, colorectal, small bowel
Other Name: HIPEC

Gastric and Pancreato-biliary
MMC Mitomycin + CDDP Cisplatin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0
Device: HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0
Gastric and Pancreato-biliary HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min

Mesothelioma and Sarcoma
CDDP Cisplatin + Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0
Device: HIPEC: CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0
CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0 Mesothelioma and Sarcoma




Primary Outcome Measures :
  1. measure treatment response to HIPEC and tumor debulking [ Time Frame: 10 years ]

    To determine Overall Survival HIPEC and tumor debulking in patients with the following malignancies:

    Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical cancers).

    GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon, appendix).

    EVALUATION CRITERIA Postoperative monitoring of toxicity and treatment (Appendix I) CR, PR, stable disease and progressive disease will be monitored. The endpoints to be examined are increase or decrease in the size of measurable ascites, tumor, and tumor markers (CA-125, CA-19.9, or CEA).

    Performance status Quality of Life Physical examination



Secondary Outcome Measures :
  1. Toxicity Monitoring [ Time Frame: 10 Years ]
    1.2. To determine the number of Grade III and Grade IV CTCAE v4.03 toxicities and complications of this treatment regimen.


Other Outcome Measures:
  1. QOL [ Time Frame: 10 years ]
    1.3. To measure treatment related QOL changes after IPHC/ HIPEC



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PATIENT ELIGIBILITY

Presumptive clinical diagnosis of a peritoneal surface cancer (PSC) prior to surgery, with no metastases outside of the abdomen.

Patients must have a performance status of 0, 1, or 2.

Patients must have adequate:

Bone marrow function: absolute neutrophil count more than or equal to 1500 and platelet count more than or equal to 100,000 Renal function: creatinine less than or equal to 1.5 mg/dl Hepatic function: bilirubin less than or equal 1.5times upper limit of normal, SGOT and alkaline phosphatase less than or equal 2.5 times upper limit of normal range Patients must have signed an informed consent. Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception.

Patients are at least 18 years of age, and under 75 years of age.

At the time of surgery, operative assessment and frozen section diagnosis of one of the following:

Primary ovarian cancer (POC) with Stage IC or greater stage Recurrent or persistent ovarian cancer (ROC) Ovarian cancer patients who desire Consolidation Chemotherapy (CC). These patients would ordinarily choose to have 12 cycles of Taxol given after standard first-line surgery and chemotherapy, and instead choose one course of IPHC as their CC.

Uterine malignancy of the corpus, or cervix with primary tumor Stage IIIA or greater, or recurrent tumor confined to the abdomen.

Metastatic mesothelioma or sarcoma confined to the abdomen. Recurrent or primary gastrointestinal cancer, with regional spread confined to the peritoneal cavity

PATIENT INELIGIBILITY

Patients with known extra-abdominal disease, or unresected bulky abdominal retroperitoneal lymph nodes.

Patients with any evidence of another malignancy within the last five years (except non-melanoma skin cancer) Patients with a known sensitivity to cisplatin, Mitomycin C, or Adriamycin. Patients with significant co-morbid medical conditions that would prevent the patient from completing treatment on this protocol, per Investigator discretion.

Patients desiring future fertility.


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): NCT02349958


Contacts
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Contact: James Lilja, MD 408-827-4274 info@bayareago.com
Contact: Augusto Bastidas, MD 408-358-4747 Drbastidas@natlsurg.com

Locations
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United States, California
James Lilja Recruiting
Los Gatos, California, United States, 95032
Contact: Heather McAvoy, LVN    408-827-4274    info@bayareago.com   
Principal Investigator: James Lilja, MD         
Sub-Investigator: Augusto Bastidas, MD         
Sponsors and Collaborators
Bay Area Gynecology Oncology
Investigators
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Principal Investigator: James Lilja, MD Bay Area Gynecology Oncology

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Responsible Party: Bay Area Gynecology Oncology
ClinicalTrials.gov Identifier: NCT02349958     History of Changes
Other Study ID Numbers: HIPEC
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Gastrointestinal Neoplasms
Uterine Neoplasms
Peritoneal Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Digestive System Neoplasms
Abdominal Neoplasms
Mesothelioma
Fever
Adnexal Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Uterine Diseases
Adenoma
Fallopian Tube Diseases
Digestive System Diseases
Gastrointestinal Diseases
Body Temperature Changes
Signs and Symptoms
Peritoneal Diseases
Cisplatin
Doxorubicin
Liposomal doxorubicin