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Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy

ABSTRACT: This pilot clinical trial studies short-infusion ziv-aflibercept in treating patients with metastatic colorectal cancer receiving combination chemotherapy. Ziv-aflibercept may stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving the drug over a shorter infusion time may result in improved efficiency and patient satisfaction.

DISEASE(S): Stage Ivb Colon Cancer,Recurrent Colon Cancer,Rectal Neoplasms,Stage Iva Rectal Cancer,Stage Ivb Rectal Cancer,Recurrent Rectal Cancer,Stage Iva Colon Cancer,Colonic Neoplasms

PROVIDER: 2151502 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Ziv-Aflibercept Followed by Ziv-Aflibercept, Fluorouracil, and Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer

Project description:This phase II trial studies how long it takes colorectal cancer resistant to standard treatment to grow while receiving treatment with ziv-aflibercept, and how well adding fluorouracil and leucovorin calcium to ziv-aflibercept works in treating patients with stage IV colorectal cancer after they progress on ziv-aflibercept alone. Ziv-aflibercept may stop the growth of colorectal cancer by blocking the formation of tumor blood vessels. Fluorouracil and leucovorin calcium are drugs used in chemotherapy. Fluorouracil works to stop the growth of tumors cells by preventing the cells from growing and dividing. Leucovorin calcium helps fluorouracil work better. Adding fluorouracil and leucovorin calcium to ziv-aflibercept may be an effective treatment for patients who progress on ziv-aflibercept alone.

| 2174020 | ecrin-mdr-crc

Phase 2 trial of FOLFIRI plus ziv-aflibercept in patients with colorectal cancer previously treated with oxaliplatin, fluoropyrimidins, bevacizumab, and trifluridine/tipiracil

Project description:Interventions: FOLFIRI plus ziv-aflibercept (Day 1) Ziv-aflibercept, 4 mg/kg, intravenously (IV) over 60 min (Day 1) Irinotecan, 150 mg/m2, IV over 90 min (Day 1) Leucovorin (l-LV), 200 mg/m2, IV over 120 min (Day 1) 5-FU, 400 mg/m2, bolus (Day 1-3) 5-FU, 2400 mg/m2, continuous infusion over 46 h Repeat the above every two weeks The dose of irinotecan can be reduced to 120 mg/m2 if patients are homozygous for UGT1A1*28 or UGT1A1*6, or heterozygous for both UGT1A1*28 and UGT1A1*6.;C480833,C533178;FOLFIRI, ziv-aflibercept Primary outcome(s): progression free survival Study Design: single arm study, open(masking not used), historical control, single assignment, treatment purpose

| 2614963 | ecrin-mdr-crc

Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer

Project description:FC-8 is a Phase II, multi-center randomized study of a continuation regimen of 5-FU/LV with ziv-aflibercept or 5-FU/LV alone (control arm) following the induction regimen of mFOLFOX6 and ziv-aflibercept as first-line therapy for patients with metastatic colorectal cancer. The primary aim of the study is to determine the value of adding ziv-aflibercept to the continuation regimen of 5-FU/LV in improving progression-free survival (PFS) of patients with metastatic colorectal cancer who have achieved at least stable disease after induction therapy. The secondary aim is to determine the overall objective response rate (complete, partial or stable responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

| 2147570 | ecrin-mdr-crc

Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer

Project description:This phase I trial studies the side effects and best dose of ziv-aflibercept when given together with pembrolizumab in treating patients with solid tumors that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ziv-afibercept works by decreasing blood and nutrient supply to the tumor, which may result in shrinking the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ziv-aflibercept together with pembrolizumab may be a better treatment for patients with advanced solid tumors.

| 2178898 | ecrin-mdr-crc

Ziv-aflibercept in metastatic colorectal cancer.

Project description:The combination of cytotoxic chemotherapy and antiangiogenic agents has become a conventional treatment option for patients with metastatic colorectal cancer. Ziv-aflibercept is a fusion protein which acts as a decoy receptor for vascular endothelial growth factor (VEGF)-A, VEGF-B, and placental growth factor (PlGF); it was approved in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing fluoropyrimidine-based regimen. Herein we review the role of tumor angiogenesis as the rationale for antiangiogenic therapy, the clinical data associated with ziv-aflibercept, and its current role as a treatment option compared to other antiangiogenic agents, such as bevacizumab and regorafenib.

| S-EPMC3869833 | biostudies-literature

Expression profiling of mouse liver after treatment with Vascular Endothelial Growth Factor (VEGF) inhibitor aflibercept

Project description:Transcriptional profiling of mouse liver was compared between VEGF inhibitor aflibercept and control treatment after 9 weeks. 8-10 week-old SCID mice received VEGF Trap protein (aflibercept) subcutaneously twice per week at 25mg per kg body weight for 9 weeks. For control groups, mice were treated with humanized Fc (Regeneron). 5 biological replicates were performed for the control group and 4 biological replicates were performed for the treatment group

2013-09-01 | E-GEOD-50519 | biostudies-arrayexpress

Intravitreal ziv-aflibercept in diabetic vitreous hemorrhage.

Project description:BackgroundTo evaluate the safety and efficacy of intravitreal ziv-aflibercept (IVZ) in the management of vitreous hemorrhage (VH) in eyes with previously lasered proliferative diabetic retinopathy (PDR).MethodsIn a prospective multicenter study, previously lasered eyes who had dense VH from PDR underwent intravitreal injection of ziv-aflibercept (IVZ) (1.25 mg aflibercept). Demographic characteristics of the patients, baseline and final logMar visual acuity, number of injections, VH clearance time, and need for vitrectomy were recorded.ResultsTwenty-seven eyes of 21 patients were included in the study. Mean age of study patients was 61.3 ± 14.1 years with mean duration of diabetes mellitus of 22.6 ± 7.8 years. Mean logMAR BCVA at baseline was 1.41 ± 1.26 (Snellen equivalent 20/514) and at the last visit 0.55 ± 0.61 (Snellen equivalent 20/70) with a mean gain of 0.86 EDTRS line (paired student t test = 5.1; p ≤ 0.001). Mean number of IVZ 2.4 ± 1.6 (range 1-6). The mean follow-up time was 11.7 ± 11.1 months (range 1-34). Mean time for visual recovery and/or VH clearance was 5.7 ± 3.3 weeks. Eyes, which required multiple injections, the interval period between injections for recurrent VH was 6.4 ± 5.2 months. No subject required vitrectomy. No ocular or systemic adverse effects were noted.ConclusionsIVZ injections had good short-term safety and efficacy for the therapy of new or recurrent VH in previously lasered eyes with PDR reducing somewhat the need for vitrectomy.Trial registration: NCT02486484.

| S-EPMC6958749 | biostudies-literature

A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer

Project description:This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety, and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line treatment of subjects with mCRC. Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice between arm A and arm B will depend on the investigator’s preference. Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods * Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days. * Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days. * Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days. Arm B (every 3 week schedule): Dosage and dosage regimen for all study periods * Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days. * Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days. * Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days.

| 2162068 | ecrin-mdr-crc

Expression profiling of mouse liver after treatment with Vascular Endothelial Growth Factor (VEGF) inhibitor aflibercept

Project description:Transcriptional profiling of mouse liver was compared between VEGF inhibitor aflibercept and control treatment after 9 weeks.

2013-09-01 | GSE50519 | GEO

Intravitreal ziv-aflibercept for macular edema following retinal vein occlusion.

Project description:AIM:To report the efficacy of intravitreal ziv-aflibercept injections in eyes with macular edema due to retinal vein occlusions (RVOs). METHODS:Consecutive patients with persistent or recurrent macular edema (central macula thickness >250 ?m) due to RVO were enrolled in this prospective study. Study eyes received intravitreal injections of ziv-aflibercept (1.25 mg/0.05 mL) at baseline. Patients were reassessed monthly for 4 months and given additional injections pro re nata for worsening best-corrected visual acuity (BCVA), intraretinal edema or subretinal fluid seen on spectral domain optical coherence tomography, or central macular thickness (CMT) measurements >250 ?m. The primary endpoint was improvement in mean CMT at 4 months. Secondary endpoints included improvement in mean BCVA, and ocular and systemic safety signals. RESULTS:Nine eyes (five central and four branch RVOs) of nine patients were enrolled. The mean ± standard deviation CMT decreased from 604±199 ?m at baseline to 319±115 ?m (P=0.001) at 1 month and to 351±205 ?m (P=0.026) at 4 months. The mean BCVA did not improve significantly from baseline (1.00 LogMAR) to the 1-month (0.74 LogMAR; P=0.2) and 4-month (0.71 LogMAR; P=0.13) visits. No safety signals were noted. CONCLUSION:In this small prospective study, intravitreal ziv-aflibercept significantly improved mean CMT in eyes with persistent or recurrent macular edema due to RVOs. Prospective, randomized trials comparing ziv-aflibercept with standard pharmacotherapy are needed to better define efficacy and safety.

| S-EPMC5038569 | biostudies-literature

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