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Trial record 38 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01668680
Recruitment Status : Terminated (No satisfactory acrual)
First Posted : August 20, 2012
Last Update Posted : July 8, 2015
Clalit Health Services
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

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.


  1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM) regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
  2. To discover predictive factors for response to this LDM regimen.


  1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of LDM chemotherapy.
  2. 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: CAPECITABINE, CELECOXIB and METHOTREXATE Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LDM anti-angiogenic chemotherapy
LDM (Low Dose Metronomic) anti-angiogenic chemotherapy includes daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE.
daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE
Other Name: Metronomic Chemotherapy

No Intervention: observation
observation only

Primary Outcome Measures :
  1. Length of progression free survival (PFS), measured in months. [ Time Frame: Up to 12 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 :
  1. Toxicity profile of treatment, defined by CTCAE Version 4.0. [ Time Frame: up to12 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.

  2. Changes in levels of angiogenic factors while under treatment: VEGF, PDGF, TSP-1 [ Time Frame: Up to 4 months. ]
    Change from baseline in levels of angiogenic factors at 4 months of treatment.

  3. Quality of life, as expressed by FACT-C. [ Time Frame: Up to 12 months. ]
    Change from baseline in parameters of Quality of life until the end of treatment, assessed up to 12 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologic (or cytologic) proof of colorectal carcinoma (CRC).
  2. Age: between 18 and 80.
  3. Sex: both sexes.
  4. Previous treatment for metastatic disease is limited to FOLFIRI+ bevacizumab.
  5. Prior adjuvant chemotherapy, with a fluoropyrimidine and/or Oxaliplatin, is allowed.
  6. 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.
  7. 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.
  8. Asymptomatic patients at break from chemotherapy.
  9. 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).
  10. Capability to understand and to sign the informed consent.

Exclusion Criteria:

  1. Concurrent any other cancer (except BCC or squamous cell carcinoma of skin).
  2. Inability to adhere to monthly visits to the oncology unit for evaluation.
  3. Presence of brain metastases.
  4. Any current or recent (within the last month) continuous treatment by steroids or by NSAIDs, or with therapeutic doses of anticoagulants for any reason.
  5. Previous radiotherapy to the only site of measurable disease.
  6. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01668680

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HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Clalit Health Services
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Principal Investigator: David Loven, MD Ha'Emek MC

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Responsible Party: HaEmek Medical Center, Israel Identifier: NCT01668680     History of Changes
Other Study ID Numbers: EMC-0047-11
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Keywords provided by HaEmek Medical Center, Israel:
Metronomic Chemotherapy
Maintenance Treatment
Colorectal Cancer Metastatic
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors