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Antiangiogenic activity of metronomic therapy with capecitabine in metastatic solid tumors of gastrointestinal tract: a phase II study - Metronomic capecitabine

Antiangiogenic activity of metronomic therapy with capecitabine in metastatic solid tumors of gastrointestinal tract: a phase II study - Metronomic capecitabine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009919-21-IT
Enrollment
Unknown
Registered
2009-11-25
Start date
2009-09-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic solid tumors of gastrointestinal tract MedDRA version: 12.1 Level: HLT Classification code 10025680 Term: Malignant miscellaneous gastrointestinal neoplasms

Interventions

Trade Name: XELODA Pharmaceutical Form: Tablet INN or Proposed INN: Capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-

Sponsors

ISTITUTO DERMOPATICO IMMACOLATA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed colorectal or gastric or colangio- or pancreatic carcinoma metastastic or locally advanced disease, not amenable to surgery. At least 1 prior chemotherapy regimen for metastatic disease for patients with ECOG PS 0-1 No prior chemotherapy regimen is scheduled for patients with an ECOG performance status of 2 At least one measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors RECIST criteria Patients over 18 ECOG Performance Status =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Life expectancy < 3 months serious and uncontrolled systemic co-morbidities second malignancy (except adequately treated in situ carcinoma of the cervix or non melanomic skin cancer) Patients who are pregnant or breast-feeding.

Design outcomes

Primary

MeasureTime frame
Main Objective: progression free survival (TTP); Serum levels of interleukins, cytochines, MIP, MCP, TNF, G-CSF, GM-CSF, FGF, VEGF in relationship with the treatment;Secondary Objective: Objective responses; toxicity evaluation; quality of life (QLQ-C30 EORTC questionnaire) ; overall survival; DPD test;Primary end point(s): progression free survival (TTP); Serum level of interleukins, cytochines, MIP, MCP, TNF, G-CSF, GM-CSF, FGF, VEGF in relationship with the treatment—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026