Ovarian Cancer Clinical Trial
— HIPEC/IPHCOfficial title:
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Using Cisplatin, Mitomycin, and Adriamycin in Peritoneal Surface Malignancies Also Known as Hyperthermic Intraperitoneal Chemotherapy.
NCT number | NCT02349958 |
Other study ID # | HIPEC |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | September 2006 |
Est. completion date | January 2022 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | James Lilja | Los Gatos | California |
Lead Sponsor | Collaborator |
---|---|
Bay Area Gynecology Oncology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | QOL | 1.3. To measure treatment related QOL changes after IPHC/ HIPEC | 10 years | |
Primary | measure treatment response to HIPEC and tumor debulking | 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 |
10 years | |
Secondary | Toxicity Monitoring | 1.2. To determine the number of Grade III and Grade IV CTCAE v4.03 toxicities and complications of this treatment regimen. | 10 Years |
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