WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer

NCT01144442 | Terminated Results DMC

• 3 other identifiers: 2009LS114WCC# 591003M78874
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor \> or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Carcinoma

Keywords

recurrent ovarian cancer; recurrent fallopian tube cancer; recurrent peritoneal carcinoma

Outcome Measures

Primary Outcomes (2)

• Clinical Response

  We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.

  After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)

• Feasibility of HIPC in Recurrent Disease Setting

  We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.

  6 months

Secondary Outcomes (3)

• Quality of Life Measurements

  Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27

• Progression-free Survival

  Up to 5 Years (intended)

• Overall Survival

  Up to 5 Years

Study Arms (1)

HIPC Treatment

EXPERIMENTAL

Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin; Other: Isotonic saline (perfusate); Procedure: Surgery; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Hyperthermic intraperitoneal chemotherapy with Carboplatin DRUG

Carboplatin at a dose of 1000mg/m\^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes.

HIPC Treatment

Isotonic saline (perfusate) OTHER

The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.

Also known as: saline

HIPC Treatment

Surgery PROCEDURE

The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus. If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach.

HIPC Treatment

Carboplatin DRUG

The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

HIPC Treatment

Paclitaxel DRUG

The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Also known as: Taxol

HIPC Treatment

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according.
• Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual.
• End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm.
• Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease.
• Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma.
• Patients must have platin sensitive disease, defined as a recurrence occurring greater than 6 months from cessation of original treatment.
• Patients must have a performance status of 0, 1, 2.
• Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) ≥1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
• Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
• Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
• Patients who have signed an Institutional Review Board (IRB) approved informed consent.
• Female patients 16-90 years of age.
• Patients must be deemed medically able to undergo a secondary surgical procedure.
• Patient eligibility for systemic chemotherapy following HIPC:
• Patients must have successfully completed HIPC within 6 weeks of first prescribed intravenous carboplatin and taxane cycle.

You may not qualify if:

• Patients with known recurrent disease outside the abdominal cavity.
• Patients with low malignant tumor at primary diagnosis as determined by pathologic review.
• Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy.
• Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer.
• Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis.
• Patients with history of grade 3 or greater gastrointestinal bleeding.
• Patients with a GOG performance score of 3 or 4.
• Patients deemed medically unable to tolerate the HIPC procedure by care giving physician.
• Patients with known allergy to platinum chemotherapy agents.
• Patients with equal to or greater than grade 2 neuropathy.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Carboplatin; Sodium Chloride; Surgical Procedures, Operative; Paclitaxel

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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Coordination Complexes; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Limitations and Caveats

The primary weakness of this study is the small sample size.

Results Point of Contact

• Title: Peter Argenta, MD
• Organization: Masonic Cancer Center

argenta@umn.edu

612-626-3111

Study Officials

• Peter Argenta, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 15, 2010
• Study Start: July 27, 2010
• Primary Completion: September 25, 2013
• Study Completion: May 1, 2015
• Last Updated: July 30, 2019
• Results First Posted: September 5, 2013

Record last verified: 2019-07

Locations

US (1)