Impact of Vascular Endothelial Growth Factor Gene Polymorphisms on Bevacizumab Efficacy in a Sample of Iraqi Patients With Metastatic Colorectal Cancer

NCT06843954 | Completed Phase 4 DMC

• 1 other identifier: 106-38
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a prospective one conducted within a time frame between September 2022 and April 2023. One hundred adult patients already diagnosed with CRC and received bevacizumab and chemotherapy consisting of fluorouracil and leucovorin or capecitabine in combination with either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Three to six cycles will be given, and to explore the response to treatment, the Response Evaluation Criteria in Solid Tumors (RECIST) will be used to assess the response.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (8)

• Complete response rate (CR)

  Every target lesion disappears. Any troublesome lymph nodes, whether they are target or non-target, need to have at least 10 mm removed from their short axis

  At the end of Cycle 3 (each cycle is 21 days)

• Partial Response rate (PR)

  No less than of 30% reduction in the intended lesion sum diameters, using use the baseline sum diameters as a guide

  At the end of Cycle 3 (each cycle is 21 days)

• Progressive Disease rate (PD)

  Target lesions' total diameters should rise by at least 20%, applying the smallest overall diameters serving as a guide. (Note: the emergence of one or more additional lesions is likewise regarded as progression)

  At the end of Cycle 3 (each cycle is 21 days)

• Stable Disease rate (SD)

  There is neither enough rise nor enough reduction to be acceptable as PR or PD, using the lowest total diameters as a reference

  At the end of Cycle 3 (each cycle is 21 days)

• Overall survival (OS)

  The duration by months from chance to death for all patients who received Bevacizumab was calculated additionally, we excluded any patients who were still alive or lost to follow-up at the time of assessment

  At the end of Cycle 3 (each cycle is 21 days)

• Progression free survival (PFS)

  The number of months, for all patients alive at the time of assessment from selection of patients until the first sign of disease advancement or death

  At the end of Cycle 3 (each cycle is 21 days)

• Objective Response Rate (ORR)

  It is the proportion of participants in a therapy group that, within a particular period of time, respond completely or partially to the treatment

  At the end of Cycle 3 (each cycle is 21 days)

• Disease control rate (DCR)

  The percent (%) of patients with advanced cancer who have seen a full response, only partial response, or stable illness as a result of their therapeutic intervention

  At the end of Cycle 3 (each cycle is 21 days)

Secondary Outcomes (2)

• Health related quality of life measure (HRQL)

  At the end of Cycle 3 (each cycle is 21 days)

• Adverse effects (AE) rate

  At the end of Cycle 3 (each cycle is 21 days)

Study Arms (1)

bevacizumab Group

EXPERIMENTAL

Patients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX)

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

bevacizumab (7.5mg/kg every 21 days) for minimum of 3 cycles

bevacizumab Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All eligible patients will be age over 18 years old. The risk of colorectal cancer increases with age; 90% of cases are diagnosed in individuals 50 years of age and older.
• Most patients had a performance status (WHO = 0-2), which is a score that estimates the patient's ability to perform certain activities of daily living (ADLs) without the help of others. Performance status (PS) is one of the strongest prognostic factors for survival in metastatic colorectal cancer patients.
• In all cases, the initial tumor site will be the colon.
• Adult patients already diagnosed with metastatic CRC and received bevacizumab and chemotherapy consisting of fluorouracil and leucovorin or capecitabine in combination with either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI).
• Chronic disease patients will be involved

You may not qualify if:

• Patient received bevacizumab and chemotherapy for inadequate cycles; the adequate cycle should be not less than three cycle
• Patients participating in the study and not receive bevacizumab owing to risk factors for serious adverse events like GI perforation, Wounds that don't heal, Serious bleeding, Severe high blood pressure

Sponsors & Collaborators

• Mohammed Mahmood Mohammed: lead

Study Sites (1)

Baghdad Medical city

Baghdad, 10001, Iraq

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical associated professor

Model Details: Patients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX), at the end of the study NLR and PLR data were collected.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: February 25, 2025
• Study Start: September 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

IR (1)