Status:
COMPLETED
Low Dose Metronomic Poly-chemotherapy for Metastatic CRC
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This study investigates the activity of a new regimen of treatment for patients with metastatic colorectal carcinoma. This includes a combination of well-known chemotherapy agents and anti-inflammator...
Detailed Description
Patients suffering from metastases of colorectal cancer whose tumor cells develop resistance to conventionally administered treatments are in need for new methods of treatment. While their chemothera...
Eligibility Criteria
Inclusion
- Histological (or cytological) proof of colorectal carcinoma (CRC)
- Measurable metastases
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Progressing disease following all available chemotherapy treatment lines (including chemotherapy, bevacizumab+/-ziv-aflibercept, and an epidermal growth factor receptor (EGFR) inhibitor \[if WT(wild type)-KRAS\]
- The central-radiologist's confirmation of PD\* under the last (previous) line of "conventional treatment".
- \* PD (progressive disease) by RECIST(Response Evaluation Criteria in Solid Tumors) criteria : a) there is 20% or more relative increment in the sum of diameters of target lesions in comparison with the base line sum, and their absolute increase is 5 mm. or more, or b) there appeared one or more new lesions, or c)there is substantial worsening in non-target disease
- Age: between 18 and 85
- Prior radiotherapy either as adjuvant treatment or for palliation is allowed, unless this was delivered to the only measurable lesion
- Complete blood count reflecting adequate Bone Marrow:
- Hb=/ \> 9 g/dL, ANC=/\> 1,500 Plt =/\> 75,000/mcL; 9. Adequate liver function:
- Total Bilirubin always =/\<X1.5 ULN
- ALT and AST and Alkaline Phosphatase =/ \< 2.5 X upper normal limit , although in patients with liver metastases these are acceptable if =/\< 5 X ULN; 11. Adequate renal function (serum creatinine): =/\< 1.5 X ULN. 12. Absence of any non-hematological toxicity at grade 2 or higher. 13.The patient is able to understand and ready to sign the informed consent
Exclusion
- Lack of confirmation of PD (under the pre-study treatment) by the central radiologist
- Any concurrent other active cancer (except basal cell or squamous cell carcinoma of skin and early prostate cancer or DCIS- in situ breast cancer)
- Inability to adhere to monthly visits to the oncological unit for evaluation
- Presence of brain metastases
- Continuous treatment with steroids or with NSAIDs or with anticoagulants during the last year (except micropirin)
- Previous radiotherapy to the only site of measurable disease
- Existence of active peptic ulcer or symptomatic coronary disease
- Existence of chronic inflammatory diseases, such as ulcerative colitis or Crohn's disease or rheumatoid arthritis
- Presence of ascites, and/or any other "third space" finding (eg. significant leg edema)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02280694
Start Date
January 1 2015
End Date
December 1 2019
Last Update
February 12 2020
Active Locations (1)
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1
Gastrointestinal Oncology Unit, Institute of Oncology, Davidoff Center, Rabin Medical Center, Belinson Campus,
Petach Tiqva, Israel