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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 30, 2013

Status verified

Aug 2017

Primary completion

Oct 31, 2016

Completion

Oct 31, 2016

Study Design

Enrollment

37 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Metronomic arm
  capecitabine 1100 to 1600 mg/m2/day orally in association with aflibercept 6mg/kg intravenous every 3 weeks
• Experimental: Intermittent arm
  capecitabine 1700 to 2500 mg/m2/day orally 2 weeks out of 3 and aflibercept 6mg/kg intravenous every 3 weeks

Primary Outcome Measure

To determine the maximum tolerated dose and the recommended phase II dose of capecitabine in association with aflibercept [ Time Frame: The time point of the first toxicity evaluation would be the end of the first cycle (3 weeks) ]