Back to results

Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer, Chemotherapy Effect

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

XELOX regimen

FOLFOX regimen

FOLFIRI regimen

IRI regimen

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Patients age between 18 and 80 years
Histologically confirmed metastatic colorectal cancer (mCRC)
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinotecan); progression free survival (PFS) of prior oxaliplatin or irinotecan-based chemotherapy should be at least four months without any unrecoverable toxicity. Prior target therapy was acceptable
For those who received other anti-tumor treatment, the toxicity should have been restored, with the time interval from last dose of cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥3 weeks
Life expectancy≥12 weeks
At least one measurable lesion as defined by RECIST 1.1
Acceptable hematologic, hepatic, and renal function within 7 days from screening: the blood ANC count≥1.5*10^9/L; hemoglobin≥9.0 g/dl, the blood platelet count≥80 x 10^9/L, total bilirubin<1.5*upper limits of normal(ULN), ALT and AST<2.5*ULN(< 5 *ULN for patients with live metastasis), endogenous creatinine clearance rate>50ml/min
Targeted drugs are currently not suitable or affordable

Exclusion Criteria

Receiving other systemic anti-cancer treatment within 3 weeks
Prior radiation therapy of target measurable lesion
Presence of Grade III or IV chemo-related toxicity in previous treatment without recovery to Grade II or less
With other malignant tumor in 5 years; except for cured cervical carcinoma in situ or basal cell carcinoma
Symptomatic intracranial or meningeal metastasis
History of uncontrolled seizures, central nervous system dysfunction or mental disorder
Uncontrolled pleural or peritoneal effusion
Severe life-threatening concomitant disease that might impair the safety of patients or affect the completion of treatment, according to the researcher's judgment

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

XELOX regimen

FOLFOX regimen

FOLFIRI regimen

IRI regimen

Arm Description

oxaliplatin 130mg/m2，intravenous，on Day1 capecitabine 1000mg/m2，oral，bid，on Day1-14 every three weeks

oxaliplatin 85mg/m2，intravenous，on Day1 leucovorin 400mg/m2，intravenous，on Day1 5-FU 400mg/m2，intravenous，on Day1 5-FU 2.4g/m2，CIV 46h every two weeks

irinotecan 85mg/m2，intravenous，on Day1 leucovorin 400mg/m2，intravenous，on Day1 5-FU 400mg/m2，intravenous，on Day1 5-FU 2.4g/m2，CIV 46h every two weeks

irinotecan single agent 180mg/m2，intravenous，on Day1 every two weeks

Outcomes

Primary Outcome Measures

PFS

progression free survival

Secondary Outcome Measures

overall survival

Full Information

NCT ID

NCT03485027

First Posted

March 26, 2018

Last Updated

April 2, 2018

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03485027

Brief Title

Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer

Official Title

A Phase II Clinical Trial of Prior Regimen Rechallenge in Third or Later-line Chemotherapy for Patients With Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 24, 2018 (Actual)

Primary Completion Date

January 24, 2020 (Anticipated)

Study Completion Date

January 24, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.

Detailed Description

The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen. Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent

6. Conditions and Keywords

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

Metastatic Colorectal Cancer, Chemotherapy Effect

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

investigator chose the optimal reintroduction regimen for chemotherapy according to criteria

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XELOX regimen

Arm Type

Experimental

Arm Description

oxaliplatin 130mg/m2，intravenous，on Day1 capecitabine 1000mg/m2，oral，bid，on Day1-14 every three weeks

Arm Title

FOLFOX regimen

Arm Type

Experimental

Arm Description

oxaliplatin 85mg/m2，intravenous，on Day1 leucovorin 400mg/m2，intravenous，on Day1 5-FU 400mg/m2，intravenous，on Day1 5-FU 2.4g/m2，CIV 46h every two weeks

Arm Title

FOLFIRI regimen

Arm Type

Experimental

Arm Description

irinotecan 85mg/m2，intravenous，on Day1 leucovorin 400mg/m2，intravenous，on Day1 5-FU 400mg/m2，intravenous，on Day1 5-FU 2.4g/m2，CIV 46h every two weeks

Arm Title

IRI regimen

Arm Type

Experimental

Arm Description

irinotecan single agent 180mg/m2，intravenous，on Day1 every two weeks

Intervention Type

Drug

Intervention Name(s)

XELOX regimen

Intervention Description

reintroduction of the XELOX regimen in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant

Intervention Type

Drug

Intervention Name(s)

FOLFOX regimen

Intervention Description

reintroduction of the FOLFOX regimen in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant

Intervention Type

Drug

Intervention Name(s)

FOLFIRI regimen

Intervention Description

reintroduction of the FOLFIRI regimen in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant

Intervention Type

Drug

Intervention Name(s)

IRI regimen

Intervention Description

reintroduction of the irinotecan single agent in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant

Primary Outcome Measure Information:

Title

PFS

Description

progression free survival

Time Frame

from the time signing of informed consent form(ICF) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary Outcome Measure Information:

Title

Description

overall survival

Time Frame

from the time signing of ICF until the date of death from any cause, assessed up to 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Patients age between 18 and 80 years Histologically confirmed metastatic colorectal cancer (mCRC) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinotecan); progression free survival (PFS) of prior oxaliplatin or irinotecan-based chemotherapy should be at least four months without any unrecoverable toxicity. Prior target therapy was acceptable For those who received other anti-tumor treatment, the toxicity should have been restored, with the time interval from last dose of cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥3 weeks Life expectancy≥12 weeks At least one measurable lesion as defined by RECIST 1.1 Acceptable hematologic, hepatic, and renal function within 7 days from screening: the blood ANC count≥1.5*10^9/L; hemoglobin≥9.0 g/dl, the blood platelet count≥80 x 10^9/L, total bilirubin<1.5*upper limits of normal(ULN), ALT and AST<2.5*ULN(< 5 *ULN for patients with live metastasis), endogenous creatinine clearance rate>50ml/min Targeted drugs are currently not suitable or affordable Exclusion Criteria Receiving other systemic anti-cancer treatment within 3 weeks Prior radiation therapy of target measurable lesion Presence of Grade III or IV chemo-related toxicity in previous treatment without recovery to Grade II or less With other malignant tumor in 5 years; except for cured cervical carcinoma in situ or basal cell carcinoma Symptomatic intracranial or meningeal metastasis History of uncontrolled seizures, central nervous system dysfunction or mental disorder Uncontrolled pleural or peritoneal effusion Severe life-threatening concomitant disease that might impair the safety of patients or affect the completion of treatment, according to the researcher's judgment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chenchen Wang, M.D

Phone

+18017317880

wccnancy2003@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weijian Guo, M.D

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chenchen Wang, M.D

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer

We'll reach out to this number within 24 hrs