HIPEC for Peritoneal Carcinomatosis

NCT02040142 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 11-09-332
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study investigating the new treatment of surgery combined with intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved by the U.S. Food and Drug Administration (FDA)for many different cancers including gastrointestinal cancer. Giving mitomycin C via the intraperitoneal route is not FDA approved and is an investigation therapy. Cytoreductive surgery plus intraperitoneal chemotherapy can be offered as standard of care outside of a clinical trial. However, since this is an unproven and potentially more effective but a more toxic approach, the investigators are performing this procedure under an IRB approved clinical trial in order to better evaluate the risks and benefits of this approach. A standardized, evidence-based approach is currently lacking for patients with peritoneal surface malignancy from gastrointestinal origin. A clinical trial with surgical quality assurance and modern hyperthermic intraperitoneal chemotherapy incorporating critical assessment of disease burden, determinants of complete cytoreduction, treatment-related toxicity, quality of life and survival is imperative. Theoretically, cytoreductive surgery is performed to treat macroscopic disease, and hyperthermic intraperitoneal chemotherapy is used to treat microscopic residual disease with the objective of removing disease completely in a single procedure.

Conditions

Peritoneal Carcinomatosis; Colorectal Cancer; Appendiceal Cancer; Peritoneal Mesothelioma; Pseudomyxoma Peritonei; Gastric Cancer

Keywords

Hyperthermic Intraperitoneal Mitomycin c; HIPEC; Cytoreduction

Outcome Measures

Primary Outcomes (2)

• Completeness of Cytoreduction

  Completeness of cytoreduction will be estimated and recorded using a complete cytoreduction (CC) which corresponds to a residual disease (RR) score. Completeness of Cytoreduction (CC) scores range from CC0 - CC3 and correlate to residual disease as follows: CC0 = R0: No Disease, complete removal of all visible tumor with negative cytology or microscopic margin CC1 = R1: \<= 0.25 cm; complete removal of all visible tumor with positive cytology or microscopic margin CC2 = R2a: 0.25-2.5 cm; minimal residual tumor, nodule(s) ≤ 0.5 cm CC3 =R2b: \>=2.5 cm; gross residual tumor, nodule(s), \> 0.5, but ≤ 2 cm CC3 =R2c: \>=2.5 cm; extensive disease remaining, nodule(s) \> 2 cm

  Up through study discontinuation or 12 months after study treatment, whichever occurs first

• Perioperative and Postoperative Morbidity and Mortality

  Perioperative and Postoperative morbidity and mortality will be determined in patients with peritoneal carcinomatosis of colorectal, gastric, appendical, pseudomyxoma peritonei and peritoneal mesothelioma origin undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with Mitomycin- C. The number of peri/postoperative deaths up to 30 days following the time of surgery will be recorded.

  Up to 30 days following surgery

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

Study Arms (1)

HIPEC + Mitomycin C

EXPERIMENTAL

HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, will be administered into the inflow line of the perfusion circuit once target temperature is reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, will be administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period has elapsed, the perfusate will be drained into the waste reservoir. The peritoneal cavity will be rinsed/washed-out.

Procedure: HIPEC; Drug: Mitomycin C

Interventions

HIPEC PROCEDURE

Also known as: Hyperthermic Intraperitoneal Chemotherapy

HIPEC + Mitomycin C

Mitomycin C DRUG

HIPEC + Mitomycin C

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Capable of providing informed consent.
• The patient who has not previously received hyperthermic intraperitoneal chemotherapy must have histopathologically or cytologically confirmed cancer of colorectal, appendiceal, peritoneal mesothelioma, pseudomyxoma or gastric origin with known synchronous or metachronous disease dissemination limited to the peritoneal surfaces.
• The patient must have documented disease limited to the peritoneal surface, amenable to complete cytoreduction indicated by:
• Disease confined to the peritoneal surfaces
• No parenchymal liver metastases
• No evidence of clinical, biochemical or radiological biliary obstruction
• Small volume of disease in the gastro-hepatic ligament defined by a \< 5cm mass in the epigastric region on cross-sectional imaging
• No clinical or radiological evidence of hematogenous or distant nodal metastasis
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Absolute neutrophil count (ANC) \> 1200/mm3, white blood cell count (WBC) \> 4000/mm3 and platelet count \> 150,000/mm3
• An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible).
• Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin \> 1.5 mg/dL eligible only with Gilbert's syndrome);
• alkaline phosphatase \< 2.5 times the upper limit of normal; and/or
• AST \< 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal

You may not qualify if:

• The patients have documented disease beyond the peritoneal surfaces, which prevent achieving complete cytoreduction as indicated by:
• Evidence of distant hematogenous metastatic disease or distant nodal metastases
• Evidence of parenchymal hepatic metastases
• Evidence of clinical, biochemical or radiological biliary obstruction
• Evidence of gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity which limits ability to obtain complete cytoreduction
• Significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease.
• Active systemic infections, coagulation disorders, or other major medical illnesses precluding major surgery.
• Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy or radiologic studies.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Department of Surgery, Montefiore Medical Center- Weiler Division

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Peritoneal Neoplasms; Colorectal Neoplasms; Appendiceal Neoplasms; Pseudomyxoma Peritonei; Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Mitomycin

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cecal Neoplasms; Cecal Diseases; Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. John McAuliffe, Associate Professor Department of Surgery and Department of Pathology
• Organization: Montefiore Medical Center

jomcauli@montefiore.org

718-379-6865

Study Officials

• John McAuliffe, M.D.

  Department of Surgery, Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: January 20, 2014
• Study Start: November 1, 2011
• Primary Completion: October 13, 2022
• Study Completion: August 19, 2024
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)