HOT: HIPEC in Ovarian Cancer as Initial Treatment

Fallopian Tube Cancer Clinical Trial

— CRS/HIPEC  

Official title:

Phase II Randomized Study: Cytoreductive Surgery (CRS) With/Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Adjuvant Chemotherapy as Initial Treatment of Ovarian, Fallopian Tube, & Primary Peritoneal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02124421
• Other study ID #: MMC-2014-17
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: April 2028

Study information

• Verified date: October 2023
• Source: Mercy Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary endpoints:

• To assess the feasibility of recruitment

• Compare complication rates between the two study arms: CRS with HIPEC and CRS alone.

Secondary endpoints:

• To determine risk factors for morbidity and mortality

• Assess completion rate of 6 cycles of systemic chemotherapy

• To determine progression free survival at 24 months

• To determine overall survival at 1, 3, and 5 years

• Evaluate health related quality of life

Patients who meet study criteria will be randomized into one of two treatment arms: 1) cytoreductive surgery (CRS) with carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by IV combination chemotherapy with carboplatin and paclitaxel or 2) cytoreductive surgery (CRS) alone followed by adjuvant intraperitoneal (IP) and IV chemotherapy with combination cisplatin and paclitaxel for newly diagnosed advanced stage (stage III/IV) ovarian, fallopian tube or primary peritoneal cancer. Both study arms will receive 6 cycles of adjuvant chemotherapy.

Twenty-four patients will undergo CRS with HIPEC performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175mg/m2) for 6 cycles postoperatively.

Twenty-four patients will undergo CRS only performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by IV/IP chemotherapy with Day 1: IV paclitaxel (135 mg/m2), Day 2: IP cisplatin (75 mg/m2), and Day 8: IP paclitaxel (60 mg/m2) for 6 cycles postoperatively.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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:

1. Absolute neutrophil count (ANC) =1,000/mm3

2. Platelets =100,000/mm3

3. Hemoglobin = 8.5 g/dL

• Renal function:

1) Creatinine =1.5 times the upper limit of normal or a calculated creatinine clearance =60ml/min

• Hepatic function:

1. Bilirubin =1.5 times upper limit of normal

2. Alanine aminotransferase (ALT) =3 times upper limit of normal

3. Aspartate aminotransferase (AST) =3 times upper limit of normal

• Blood coagulation parameters:

1. Prothrombin time (PT) with International Normalized Ratio of =1.5 and a partial prothrombin time (PTT) =1.5 times upper limit of normal

2. For patients on full dose warfarin, in range International Normalized Ratio (usually between 2 and 3) and

3. Partial prothrombin time (PTT) <1.2 times upper limit of normal

4. Candidate for administration of postoperative standard platinum-based combination systemic chemotherapy (adequate bone marrow, renal, hepatic function, and blood coagulation parameters)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Ovarian Carcinoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma
• Stage III Ovarian Cancer
• Stage IV Ovarian Cancer

Intervention

Procedure:
• Cytoreductive Surgery (CRS)
Cytoreductive surgery

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

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

Procedure:
• Hyperthermic intraperitoneal chemotherapy
Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6

Drug:
• Carboplatin
AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.
• Paclitaxel
175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles
• Paclitaxel
Day 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
• Cisplatin
Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk factors for morbidity and mortality	Determine percent of patients wtih Grade I-V adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE).	During & at study completion
Primary	Post-operative complication rates	Compare post-operative complication rates between study arms	30 days post-operative
Secondary	Assessment of quality of life	FACT-O questionnaire to assess quality of life in both study arms	Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Secondary	Evaluate the rate of progression free survival	Time from intervention to disease recurrence	at 24 months
Secondary	Evaluate overall survival	Time from intervention to death	at 1, 3, and 5 years