Assessment of combination chemotherapy in colorectal cancer patients with peritoneal metastases by analysing obtained tumor tissue samples (CARCINOSIS).

Phase 1

• Conditions: Patients with peritoneal carcinomatosis from colorectal cancer are treated with a combination chemotherapy (FOLFOXIRI+ Bevacizumab); MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10034672 Term: Peritoneal metastases System Organ Class: 100000016861; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002917-30-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-22
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

General inclusion criteria:
1.Histologically confirmed carcinoma of the colon or rectum with synchronous or metachronous peritoneal metastasis.
2.Male and female patients, aged = 18 years.
3.ECOG performance score of = 2.
4.Life expectancy = 26 weeks.
5.Neutrophils (absolute count) = 1.5 g/l.
6.Platelet count = 100 g/l.
7.Hemoglobin > 9 g/dL.
8.Total bilirubin = 1.8 mg/dl.
9.AST and ALT = 88 U/l (= 175 U/l if liver metastases present).
10.Alkaline phosphatase = 325 U/l (= 650 U/l if liver metastases present).
11.Calculated creatinine clearance > 50 mL/min OR serum creatinine = 1.5 mg/dl.
12.Proteinuria < 2+ by dipstick or urine protein <1 g by 24-hr urine collection.
13.Not pregnant or nursing.
14.Negative pregnancy test (for females of childbearing potential)
15.Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment.
16.Written informed consent.
Resectability:
17.General condition considered feasible for major abdominal surgery after systemic chemotherapy.
18.=3 liver metastases amenable to curative resection using a minor liver resection.

Inclusion criteria for control group:
- Histologically confirmed carcinoma of the colon or rectum without synchronous or metachronous (up to two years) peritoneal metastasis.
- Male and female patients, aged = 18 years
- pT stage 2 or 3 (or 4)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

General exclusion criteria:
1.Major surgical procedure or significant traumatic injury within 28 days prior to study enrolment (surgical exploration with diagnostic biopsy/sampling of peritoneal tumor deposits but without bowel resection or comparable surgical procedure is allowed).
2.History of previous cytoreductive surgery in combination with hyperthermic intraperitoneal chemotherapy.
3.Pregnancy or lactation.
4.Inability or unwillingness to comply with the protocol.

Resectability:
5.Evidence of current extraabdominal metastatic disease. Prior extraabdominal metastatic disease is allowed, provided that it has been curatively resected =6 months before study entry and that current staging shows no evidence of disease recurrence.
6.>3 liver metastases or any liver metastases not amenable to upfront curative resection using a minor liver resection.

Prior treatment:
7.Prior systemic chemotherapy completed =3 months before study inclusion.
8.Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.

Other disease or conditions:
9.History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) unless adequately treated with standard medical therapy (e.g. uncontrolled seizures)
10.Untreated brain metastases, spinal cord compression or primary brain tumors.
11.Past or current history (within the last 2 years prior to treatment start) of other malignancies except colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
12.Clinically significant cardiovascular disease, for example CVA, myocardial infarction (£ 12 months before treatment start), unstable angina, New York Heart Association (NYHA) > Class II congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension.
13.Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.
14.Any previous venous thromboembolism > NCI CTCAE Grade 3.
15.Prior history of hypertensive crisis or hypertensive encephalopathy.
16.Evidence of bleeding diathesis or significant coagulopathy.
17.History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to the first study treatment.
18.Known hypersensitivity to any of the study drugs.
19.Serious, non-healing wound, ulcer or bone fracture.
20.Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.
21.Symptomatic peripheral neuropathy = grade 1 according to the NCI Common Toxicity Criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified