First-line Combination of Capecitabine and Oxaliplatin + Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Istituto Oncologico Veneto IRCCS1 site in 1 country121 target enrollmentNovember 1, 2017

ConditionsElderly Metastatic Colorectal Cancer Patients

DrugsCapecitabine Oxaliplatin Bevacizumab

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Elderly Metastatic Colorectal Cancer Patients
Sponsor: Istituto Oncologico Veneto IRCCS
Enrollment: 121
Locations: 1
Primary Endpoint: Progression Free Survival (PFS)
Status: Active, not recruiting
Last Updated: 17 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Oxaliplatin-based doublets plus bevacizumab are standard first-line therapy options for patients (pts) with metastatic colorectal cancer (mCRC). Slight adjustments in chemo-dosage are commonly applied in routinely practice to elderly pts, but those modified schedules have never been standardized
The addition of oxaliplatin versus no oxaliplatin to treatment with 5-fluorouracil in older and frail untreated pts with mCRC resulted in a non-statistically significant trend toward improvement in Progression Free Survival (PFS) and a lack of benefit in Overall Survival (OS)
In elderly pts deemed unfit for an upfront combined chemotherapy a fluoropyrimide-based monotherapy plus bevacizumab is considered a reasonable first-line treatment
Clinical definition of elderly (over 70 years old) pts with CRC that may deserve a more or less intensive combination therapy is still debated. The cut-off of 75 years old combined with ECOG PS assessment is a reasonable approach for clearly defining candidates to different approaches
Several geriatric screening tools have been used to identify pts with a geriatric profile potentially predicting for overall survival and risk of toxicity. The G8 screening tool has been already validated in pts with cancer showing the strongest prognostic value for OS; the CRASH score is able to stratify pts according an estimated risk of treatment-related toxicities

On the basis of these considerations, we designed the present observational study of first-line therapy with bevacizumab in combination with capecitabine and oxaliplatin in previously untreated elderly pts affected by unresectable mCRC in order to evaluate its efficacy in real world practice (as measured by progression free survival)

Registry

clinicaltrials.gov

Start Date

November 1, 2017

End Date

April 1, 2027

Last Updated

17 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Istituto Oncologico Veneto IRCCS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically proven diagnosis of colorectal cancer.
•Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
•Indication to oxaliplatin, capecitabine and bevacizumab as first line treatment.
•At least one measurable lesion according to RECIST1.1 criteria.
•Availability of a tumoral sample (primary and/or metastatic sites).
•Age ≥ 70 years.
•ECOG PS (Eastern Cooperative Oncology Group - Performance Status) 1 or 2 for pts aged 70 to 75 years; ECOG PS 0 or 1 for pts aged \> 75 years.
•Life expectancy of at least 12 weeks.
•Previous adjuvant chemotherapy allowed only if with fluoropyrimidine monotherapy and more than 6 months elapsed between the end of adjuvant and first relapse.
•Laboratory Requirements:

Exclusion Criteria

•Previous adjuvant oxaliplatin-containing chemotherapy.
•Previous treatment with bevacizumab.
•Previous systemic treatment for the metastatic disease.
•Previous radiotherapy treatment to any site within 4 weeks before the study.
•Evidence of untreated brain metastases or spinal cord compression or primary brain tumours.
•History or evidence upon physical examination of CNS disease unless adequately treated.
•Symptomatic peripheral neuropathy \> 1 grade NCIC-CTG criteria.
•Serious, non-healing wound, ulcer, or bone fracture.
•Evidence of bleeding diathesis or coagulopathy.
•Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: Up to 28 months

PFS is defined as the time from study enrollment to the first documentation of objective disease progression or death due to any cause, whichever occurs first.