NCT01843725

Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers

Modulation of Metabolic Index in Tailoring Treatment of Incurable Metastatic ColoRectal Cancer (CRC) Program 1.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective non randomized, non-comparative, dose escalation, two arms open phase I trial to assess the safety and tolerability of capecitabine given in combination with aflibercept in patients with measurable or evaluable, chemorefractory digestive tumors or breast tumors in terms of the Maximum Tolerated Dose (MTD) and the Dose-Limiting Toxicities (DLTs), To establish the Recommended Phase II Dose (RP2D) of capecitabine in combination with Aflibercept.

Detailed description

Aflibercept has been found to be active with a broad pharmacological index against early and advanced stage disease in a variety of preclinical solid tumor models including sarcomas, and ovarian, prostate, mammary, colon, and gastric carcinomas either as a single agent or in combination with cytotoxic agents. Metronomic chemotherapy, namely administration of continuous low-dose chemotherapy at close, regular intervals, with no prolonged drug-free interruptions, bases its rationale on the fact that virtually all classes of cancer chemotherapeutic drugs are designed to damage DNA or disrupt microtubules of dividing cells. Endothelial cell division takes place during new blood vessel formation, including tumour angiogenesis. Frequent administration of most cytotoxic agents at low doses is thought to increase their putative antiangiogenic activity. This strategy lowers the toxicity and theoretically the risk of emergence of drug-resistant tumour cells compared to classic maximum tolerated dose (MTD)-based chemotherapy.

Conditions

• Metastatic Colorectal Cancers
• Metastatic Gastric Cancers
• Metastatic Oesophageal Cancers
• Metastatic Pancreatic Cancers
• Metastatic Biliary Cancers
• Metastatic Breast Cancers

Interventions

Type	Name	Description
DRUG	capecitabine	escalation dose of capecitabine continuously
DRUG	aflibercept	Intravenous 6mg/kg every 3 weeks
DRUG	Capecitabine	dose escalation, from 1700 to 2500mg/m2/day 2 weeks out of 3

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-05-01
• Last updated: 2018-01-31

Locations

1 site across 1 country: Belgium