HOT: HIPEC in Ovarian Cancer as Initial Treatment

NCT02124421 | Active Not Recruiting Phase 2

• 1 other identifier: MMC-2014-17
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Conditions

Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Ovarian Carcinoma; Fallopian Tube Carcinoma

Keywords

Ovarian cancer; Cytoreductive surgery; Hyperthermic Intraperitoneal chemotherapy; Systemic chemotherapy; Primary peritoneal carcinoma; Fallopian Tube cancer; Intraperitoneal chemotherapy; IV/IP chemotherapy; IV chemotherapy

Outcome Measures

Primary Outcomes (1)

• Post-operative complication rates

  Compare post-operative complication rates between study arms

  30 days post-operative

Secondary Outcomes (3)

• Assessment of quality of life

  Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5

• Evaluate the rate of progression free survival

  at 24 months

• Evaluate overall survival

  at 1, 3, and 5 years

Other Outcomes (1)

• Risk factors for morbidity and mortality

  During & at study completion

Study Arms (2)

CRS with adjuvant IV/IP chemotherapy

ACTIVE COMPARATOR

Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up

Procedure: Cytoreductive Surgery (CRS); Drug: Adjuvant Chemotherapy; Other: Questionnaire; Drug: Paclitaxel; Drug: Cisplatin

CRS/HIPEC with adjuvant IV chemotherapy

EXPERIMENTAL

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up

Procedure: Cytoreductive Surgery (CRS); Drug: Adjuvant Chemotherapy; Other: Questionnaire; Procedure: Hyperthermic intraperitoneal chemotherapy; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Cytoreductive Surgery (CRS) PROCEDURE

Cytoreductive surgery

Also known as: CRS

CRS with adjuvant IV/IP chemotherapy; CRS/HIPEC with adjuvant IV chemotherapy

Adjuvant Chemotherapy DRUG

Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles

Also known as: Post-operative chemotherapy, Systemic chemotherapy

CRS with adjuvant IV/IP chemotherapy; CRS/HIPEC with adjuvant IV chemotherapy

Questionnaire OTHER

Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants

Also known as: FACT-O Questionnaire

CRS with adjuvant IV/IP chemotherapy; CRS/HIPEC with adjuvant IV chemotherapy

Hyperthermic intraperitoneal chemotherapy PROCEDURE

Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6

Also known as: HIPEC

CRS/HIPEC with adjuvant IV chemotherapy

Carboplatin DRUG

AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.

Also known as: Paraplatin

CRS/HIPEC with adjuvant IV chemotherapy

Paclitaxel DRUG

175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles

Also known as: Taxol

CRS/HIPEC with adjuvant IV chemotherapy

Cisplatin DRUG

Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles

Also known as: CDDP

CRS with adjuvant IV/IP chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical presentation of ovarian, fallopian tube or primary peritoneal cancer
• Stage III/IV disease
• No prior treatment or significant surgery for the management of ovarian, fallopian tube, or primary peritoneal carcinoma; History of laparoscopic procedures to obtain diagnostic biopsies will be permitted in the study
• Histological confirmation
• Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
• ≤1 cm residual disease at the completion of the cytoreductive surgery (GOG criteria for optimally cytoreduction)
• Bone marrow function:
• Absolute neutrophil count (ANC) ≥1,000/mm3
• Platelets ≥100,000/mm3
• Hemoglobin ≥ 8.5 g/dL
• Renal function:
• \) Creatinine ≤1.5 times the upper limit of normal or a calculated creatinine clearance ≥60ml/min
• Hepatic function:
• Bilirubin ≤1.5 times upper limit of normal
• Alanine aminotransferase (ALT) ≤3 times upper limit of normal

You may not qualify if:

• Any prior treatment modality for the diagnosis of ovarian, fallopian tube, or primary peritoneal cancerPrior surgical attempt of cytoreductive surgery
• Stage I/II disease
• Presence of other invasive malignancies or evidence of other cancer within the past 3 years
• Known active acute hepatitis and confirmed diagnosis of HIV
• Active systemic infection that requires use of parenteral antibiotics
• History of acute coronary syndromes (ACS), within the last 6 months, according to AHA definitions
• New York Heart Association (NYHA) Class II or higher congestive heart failure according to American Heart Association (AHA) definitions
• Canadian Cardiovascular Society (CCS) Class II or higher angina grade according to AHA definitions
• Uncontrolled hypertension defined as \> 140/90 and not cleared for surgery at time of consent by cardiologist
• History of cerebral artery disease and prior stroke according to AHA definitions in the last 6 months
• Renal insufficiency with serum creatinine level ≥1.5 times the upper limit of normal or calculated creatinine clearance \<60 ml/min
• Patients with concurrent severe medical problems unrelated to malignancy that will preclude compliance with the study or places at an unacceptable risk for participation in the study determinate by study investigators
• Pregnant women are excluded from this study because carboplatin is category D agent with the potential of teratogenic effects. Due to potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin, breastfeeding should be discontinued
• Life expectancy of \< 12 weeks

Sponsors & Collaborators

• Mercy Medical Center: lead

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Cytoreduction Surgical Procedures; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Surveys and Questionnaires; Hyperthermic Intraperitoneal Chemotherapy; Carboplatin; Paclitaxel; Cisplatin

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics; Drug Therapy; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Hyperthermia, Induced; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Teresa Diaz-Montes, M.D.

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

• Armando Sardi, M.D.

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

US (1)