Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Colorectal Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Aflibercept

Antimetabolites

Angiogenesis Inhibitors

Growth Inhibitors

capecitabine 1100 to 1600 mg/m2/day orally in association with aflibercept 6mg/kg intravenous every 3 weeks

capecitabine 1700 to 2500 mg/m2/day orally 2 weeks out of 3 and aflibercept 6mg/kg intravenous every 3 weeks

escalation dose of capecitabine continuously

capecitabine

aflibercept

dose escalation, from 1700 to 2500mg/m2/day 2 weeks out of 3

Alain Hendlisz, MD

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.

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.

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.

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), the Dose-Limiting Toxicities (DLTs), and to determine the Recommended Phase II Dose (RP2D) of capecitabine in combination with aflibercept.

Jules Bordet Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers	NCT01843725	Metastatic Colo... Metastatic Gast... Metastatic Oeso... Metastatic Panc... Metastatic Bili... Metastatic Brea...	capecitabine aflibercept Capecitabine	18 Years -	Jules Bordet Institute
Phase 1 Study Testing the Combination of Aflibercept and Capecitabine in Metastatic Digestive and Breast Cancers	NCT01843725	Metastatic Colo... Metastatic Gast... Metastatic Oeso... Metastatic Panc... Metastatic Bili... Metastatic Brea...	capecitabine aflibercept Capecitabine	18 Years -	Jules Bordet Institute

Spots Global Cancer Trial Database for metastatic biliary cancers