Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

NCT01668680 | Terminated Phase 2

• 1 other identifier: EMC-0047-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

1. 1.To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
2. 2.To discover predictive factors for response to this LDM regimen.
3. 3.The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy.
4. 4.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.

Conditions

Colorectal Cancer Metastatic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months.

Secondary Outcomes (3)

• Toxicity profile of treatment, defined by CTCAE Version 4.0.

  up to12 months

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

  Up to 4 months.

• Quality of life, as expressed by FACT-C.

  Up to 12 months.

Study Arms (2)

LDM anti-angiogenic chemotherapy

EXPERIMENTAL

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

Drug: CAPECITABINE, CELECOXIB and METHOTREXATE

observation

NO INTERVENTION

observation only

Interventions

CAPECITABINE, CELECOXIB and METHOTREXATE DRUG

daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE

Also known as: Metronomic Chemotherapy

LDM anti-angiogenic chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Clalit Health Services: collaborator

Study Sites (1)

HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Interventions

Capecitabine; Celecoxib; Methotrexate

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David Loven, MD

  Ha'Emek MC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 11, 2012
• First Posted: August 20, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

IL (1)