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

Phase 1
18 Years
Not Enrolling
Metastatic Colorectal Cancers, Metastatic Gastric Cancers, Metastatic Oesophageal Cancers, Metastatic Pancreatic Cancers, Metastatic Biliary Cancers, Metastatic Breast Cancers

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Trial Information

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

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.

Inclusion Criteria:

- Histologically confirmed digestive or breast cancer that is metastatic or
unresectable, for which no curative measures are possible, and chemorefractory to all
known medications in the respective fields.

- Age ≥ 18 years.

- Life expectancy of greater than 12 weeks.

- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1.

- Normal organ and marrow function as defined below:

- Leukocytes > 3,000/microLiter (mcL)

- Hb>10g/mcL

- Absolute neutrophil count > 1,500/mcL

- Platelets > 100,000/mcL

- Total bilirubin within 2 × institutional upper limit of normal

- AST (aspartate amino transferase)/ALT (alanine amino transferase)/ALKP (Alkaline
Phosphatase) levels < 5 × institutional upper limit of normal for liver
metastases, < 2.5 ULN (Upper Limit of Normal) in case of no liver metastases

- Creatinine within 2 × institutional upper limit of normal or creatinine
clearance > 35 mL/min

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately.

- Signed written informed consent (approved by an Independent Ethics Committee (IEC))
obtained prior to any study specific baseline procedures.

Exclusion Criteria:

- Patients with malabsorption or dysfunctional GI tract.

- Participants who have had chemotherapy or radiotherapy (except limited radiotherapy
for bone metastasis for instance) within 4 weeks prior to entering the study or those
who have not recovered from adverse events due to agents administered more than 4
weeks earlier.

- Participants should not receive any other experimental agents.

- Participants with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse

- Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular
incident within the last six months.

- Major surgery within 6 weeks.

- Uncontrolled concurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women, lactation or refusal to use adequate contraceptive measures (hormonal
or barrier method of birth control, abstinence).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose and the recommended phase II dose of capecitabine in association with aflibercept

Outcome Description:

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.

Outcome Time Frame:

The time point of the first toxicity evaluation would be the end of the first cycle (3 weeks)

Safety Issue:


Principal Investigator

Amelie Deleporte, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Jules Bordet


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

July 2013

Completion Date:

April 2014

Related Keywords:

  • Metastatic Colorectal Cancers
  • Metastatic Gastric Cancers
  • Metastatic Oesophageal Cancers
  • Metastatic Pancreatic Cancers
  • Metastatic Biliary Cancers
  • Metastatic Breast Cancers
  • breast cancer
  • digestive cancer
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms