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Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer (COCHISE)

Primary Purpose

Colorectal Cancer, Primary Peritoneal Cavity Cancer

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

cetuximab

fluorouracil

leucovorin calcium

oxaliplatin

adjuvant therapy

therapeutic conventional surgery

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed colorectal adenocarcinoma meeting the following criteria:
- Exclusively peritoneal carcinomatosis (no other metastases)
- Resectable disease
Primary tumor may be same in the same location as another synchronous carcinomatosis
Patients with metastatic disease who have been in complete remission for more than 1 year are eligible regardless of prior chemotherapy

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Life expectancy ≥ 12 weeks
ANC ≥ 1.5 x 10^9/L
Platelet count ≥ 100 x 10^9/L
Hemoglobin ≥ 10 g/dL
Bilirubin ≤ 1.25 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN
Creatinine ≤ 1.25 times ULN
Creatinine clearance ≥ 30 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception
No allergy, hypersensitivity, or other contraindication to leucovorin calcium, oxaliplatin, or fluorouracil
No other noncancerous disease that would preclude study therapy
Good nutritional status
No sensitive peripheral neuropathy with functional impairment
No hypoplasia or bone marrow failure
No clinically significant cardiovascular disease within the past year (e.g., unstable angina or myocardial infarction)
No other cancer within the past 5 years unless in complete remission with the exception of cervical carcinoma in situ or basal cell cancer
No patients deprived of liberty or under supervision
No psychological, social, familial, or geographical reasons prohibiting follow-up

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 1 year since prior adjuvant chemotherapy, including prior therapy with oxaliplatin and/or cetuximab
No prophylactic phenytoin (Dihydan®, Dilantin®)
No prior yellow fever vaccine
More than 1 month since participation in another study

Sites / Locations

Institut Bergonie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy + Cetuximab

Arm Description

Surgery + Chemotherapy + Cetuximab

Outcomes

Primary Outcome Measures

Median Progression-free Survival (PFS) Time

Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary Outcome Measures

30-day Mortality Rate

Rate of deaths observed within 30 days of surgery

Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery

Overall Survival (OS) Time

OS is the delay between surgery and death

Full Information

NCT ID

NCT00766142

First Posted

October 2, 2008

Last Updated

January 5, 2021

Sponsor

Institut Bergonié

Collaborators

Assistance Publique - Hôpitaux de Paris, Centre Alexis Vautrin, Nancy, Centre Leon Berard, Institut Cancerologie de l'Ouest, Hôpital Haut-Lévêque, Clinique Francheville, Périgueux

1. Study Identification

Unique Protocol Identification Number

NCT00766142

Brief Title

Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Acronym

COCHISE

Official Title

Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

In 2008, new data highlighted that Cetuximab had no efficacy in case of KRAS mutation. As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.

Study Start Date

May 1, 2007 (undefined)

Primary Completion Date

September 17, 2013 (Actual)

Study Completion Date

September 17, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Bergonié

Collaborators

Assistance Publique - Hôpitaux de Paris, Centre Alexis Vautrin, Nancy, Centre Leon Berard, Institut Cancerologie de l'Ouest, Hôpital Haut-Lévêque, Clinique Francheville, Périgueux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.

Detailed Description

OBJECTIVES: Primary Determine the efficacy of systemic chemotherapy and cetuximab, in terms of progression-free survival at 3 years, in patients with completely resected peritoneal carcinomatosis of colorectal origin. Secondary Determine the therapeutic strategy among patients who are or are not fit to receive chemotherapy. Determine progression-free survival at 5 years and overall survival at 3 and 5 years in these patients. Determine the overall tolerability (mortality, morbidity) of this regimen, including surgery, in these patients. OUTLINE: This is a multicenter study. Patients undergo complete resection of the peritoneal carcinomatosis. Beginning 4-8 weeks after surgery, patients receive cetuximab IV over 2.5 hours. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Treatment repeats every 2 weeks for up to 12 courses. After completion of study therapy, patients are followed every 4 months for 2 years and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Primary Peritoneal Cavity Cancer

Keywords

adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Combination Chemotherapy and Cetuximab in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy + Cetuximab

Arm Type

Experimental

Arm Description

Surgery + Chemotherapy + Cetuximab

Intervention Type

Biological

Intervention Name(s)

cetuximab

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Type

Drug

Intervention Name(s)

leucovorin calcium

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Primary Outcome Measure Information:

Title

Median Progression-free Survival (PFS) Time

Description

Time Frame

Since surgery, up to 5 years

Secondary Outcome Measure Information:

Title

30-day Mortality Rate

Description

Rate of deaths observed within 30 days of surgery

Time Frame

from the date of surgery up to 30 days

Title

Mean Number of Adverse Events Per Patient, Within 30 Days of Surgery

Time Frame

from the date of surgery up to 30 days

Title

Overall Survival (OS) Time

Description

OS is the delay between surgery and death

Time Frame

from surgery, up to five years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed colorectal adenocarcinoma meeting the following criteria: Exclusively peritoneal carcinomatosis (no other metastases) Resectable disease Primary tumor may be same in the same location as another synchronous carcinomatosis Patients with metastatic disease who have been in complete remission for more than 1 year are eligible regardless of prior chemotherapy PATIENT CHARACTERISTICS: WHO performance status 0-2 Life expectancy ≥ 12 weeks ANC ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Hemoglobin ≥ 10 g/dL Bilirubin ≤ 1.25 times upper limit of normal (ULN) AST and ALT ≤ 3 times ULN Creatinine ≤ 1.25 times ULN Creatinine clearance ≥ 30 mL/min Not pregnant or nursing Fertile patients must use effective contraception No allergy, hypersensitivity, or other contraindication to leucovorin calcium, oxaliplatin, or fluorouracil No other noncancerous disease that would preclude study therapy Good nutritional status No sensitive peripheral neuropathy with functional impairment No hypoplasia or bone marrow failure No clinically significant cardiovascular disease within the past year (e.g., unstable angina or myocardial infarction) No other cancer within the past 5 years unless in complete remission with the exception of cervical carcinoma in situ or basal cell cancer No patients deprived of liberty or under supervision No psychological, social, familial, or geographical reasons prohibiting follow-up PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 1 year since prior adjuvant chemotherapy, including prior therapy with oxaliplatin and/or cetuximab No prophylactic phenytoin (Dihydan®, Dilantin®) No prior yellow fever vaccine More than 1 month since participation in another study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Serge Evrard

Organizational Affiliation

Institut Bergonié

Official's Role

Study Chair

Facility Information:

Facility Name

Institut Bergonie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31331370

Citation

Evrard S, Desolneux G, Bellera C, Esnaud T, Becouarn Y, Collet D, Chafai N, Marchal F, Cany L, Lermite E, Rivoire M, Mathoulin-Pelissier S. Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial. BMC Res Notes. 2019 Jul 22;12(1):450. doi: 10.1186/s13104-019-4476-9.

Results Reference

result

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Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

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