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Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

Primary Purpose

Colorectal Cancer Metastatic

Status

Terminated

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

CAPECITABINE, CELECOXIB and METHOTREXATE

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring Metronomic Chemotherapy, Anti-Angiogenic, Maintenance Treatment, Colorectal Cancer Metastatic

Eligibility Criteria

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

Inclusion Criteria:

Histologic (or cytologic) proof of colorectal carcinoma (CRC).
Age: between 18 and 80.
Sex: both sexes.
Previous treatment for metastatic disease is limited to FOLFIRI+ bevacizumab.
Prior adjuvant chemotherapy, with a fluoropyrimidine and/or Oxaliplatin, is allowed.
Prior radiotherapy, either as adjuvant treatment or palliation of metastatic sites is allowed, provided that there are other non-irradiated foci of disease for evaluation.
Persistent remission, either complete, partial or minimal response (CR, PR or MR) or stable disease (SD), one year+/-one month from initiation of first line treatment for mCRC.
Asymptomatic patients at break from chemotherapy.
Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL).
Capability to understand and to sign the informed consent.

Exclusion Criteria:

Concurrent any other cancer (except BCC or squamous cell carcinoma of skin).
Inability to adhere to monthly visits to the oncology unit for evaluation.
Presence of brain metastases.
Any current or recent (within the last month) continuous treatment by steroids or by NSAIDs, or with therapeutic doses of anticoagulants for any reason.
Previous radiotherapy to the only site of measurable disease.
Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), and/or existence of active peptic ulcer (clinically and/or by gastroscopy).

Sites / Locations

HaEmek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LDM anti-angiogenic chemotherapy

observation

Arm Description

LDM (Low Dose Metronomic) anti-angiogenic chemotherapy includes daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE.

observation only

Outcomes

Primary Outcome Measures

Length of progression free survival (PFS), measured in months.

From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.

Secondary Outcome Measures

Toxicity profile of treatment, defined by CTCAE Version 4.0.

From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.

Changes in levels of angiogenic factors while under treatment: VEGF, PDGF, TSP-1

Change from baseline in levels of angiogenic factors at 4 months of treatment.

Quality of life, as expressed by FACT-C.

Change from baseline in parameters of Quality of life until the end of treatment, assessed up to 12 months.

Full Information

NCT ID

NCT01668680

First Posted

March 11, 2012

Last Updated

July 6, 2015

Sponsor

HaEmek Medical Center, Israel

Collaborators

Clalit Health Services

1. Study Identification

Unique Protocol Identification Number

NCT01668680

Brief Title

Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

Official Title

Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Terminated

Why Stopped

No satisfactory acrual

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HaEmek Medical Center, Israel

Collaborators

Clalit Health Services

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment. Objectives: To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab. To discover predictive factors for response to this LDM regimen. Hypothesis: The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to LDM chemotherapy in metastatic CRC patients.

Detailed Description

At entry to the research protocol the up-till then administered treatment with Intra Venous FOLFIRI+BEVACIZUMAB will be stopped.Instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. If and when disease progresses the original FOLFIRI+BEVACIZUMAB treatment will be considered for re-institution.

6. Conditions and Keywords

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

Colorectal Cancer Metastatic

Keywords

Metronomic Chemotherapy, Anti-Angiogenic, Maintenance Treatment, Colorectal Cancer Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LDM anti-angiogenic chemotherapy

Arm Type

Experimental

Arm Description

LDM (Low Dose Metronomic) anti-angiogenic chemotherapy includes daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE.

Arm Title

observation

Arm Type

No Intervention

Arm Description

observation only

Intervention Type

Drug

Intervention Name(s)

CAPECITABINE, CELECOXIB and METHOTREXATE

Other Intervention Name(s)

Metronomic Chemotherapy

Intervention Description

daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE

Primary Outcome Measure Information:

Title

Length of progression free survival (PFS), measured in months.

Description

From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.

Time Frame

Up to 12 months.

Secondary Outcome Measure Information:

Title

Toxicity profile of treatment, defined by CTCAE Version 4.0.

Description

From start of the experimental treatment until the date of first documented progression or date of death of any cause,whichever came first, assessed up to 12 months.

Time Frame

up to12 months

Title

Changes in levels of angiogenic factors while under treatment: VEGF, PDGF, TSP-1

Description

Change from baseline in levels of angiogenic factors at 4 months of treatment.

Time Frame

Up to 4 months.

Title

Quality of life, as expressed by FACT-C.

Description

Change from baseline in parameters of Quality of life until the end of treatment, assessed up to 12 months.

Time Frame

Up to 12 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: Histologic (or cytologic) proof of colorectal carcinoma (CRC). Age: between 18 and 80. Sex: both sexes. Previous treatment for metastatic disease is limited to FOLFIRI+ bevacizumab. Prior adjuvant chemotherapy, with a fluoropyrimidine and/or Oxaliplatin, is allowed. Prior radiotherapy, either as adjuvant treatment or palliation of metastatic sites is allowed, provided that there are other non-irradiated foci of disease for evaluation. Persistent remission, either complete, partial or minimal response (CR, PR or MR) or stable disease (SD), one year+/-one month from initiation of first line treatment for mCRC. Asymptomatic patients at break from chemotherapy. Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL). Capability to understand and to sign the informed consent. Exclusion Criteria: Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Any current or recent (within the last month) continuous treatment by steroids or by NSAIDs, or with therapeutic doses of anticoagulants for any reason. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), and/or existence of active peptic ulcer (clinically and/or by gastroscopy).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Loven, MD

Organizational Affiliation

Ha'Emek MC

Official's Role

Principal Investigator

Facility Information:

Facility Name

HaEmek Medical Center

City

Afula

ZIP/Postal Code

18101

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

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