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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer Metastatic

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Trial Information

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


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

Up to 12 months.

Safety Issue:

No

Principal Investigator

David Loven, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ha'Emek MC

Authority:

Israel: Ministry of Health

Study ID:

EMC-0047-11

NCT ID:

NCT01668680

Start Date:

September 2012

Completion Date:

December 2014

Related Keywords:

  • Colorectal Cancer Metastatic
  • Metronomic Chemotherapy
  • Anti-Angiogenic
  • Maintenance Treatment
  • Colorectal Cancer Metastatic
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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