Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab

Conditions

• Advanced Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oxaliplatin — DRUG
  140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
• Capecitabine — DRUG
  Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
• Bevacizumab — DRUG
  10 mg/kg by vein on day 1 of a 21 day cycle.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.

Key Dates

First listed

Oct 1, 2010

Start date

Sep 30, 2010

Status verified

Mar 2019

Primary completion

Sep 26, 2018

Completion

Sep 26, 2018

Study Design

Enrollment

116 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Oxaliplatin + Capecitabine + Bevacizumab
  Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle. Bevacizumab 10 mg/kg by vein on day 1 of a 21 day cycle.
• Experimental: Oxaliplatin + Capecitabine
  Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 -14 of a 21 day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Hepatic Arterial IUnfusion (HAI) Oxaliplatin, with Oral Capecitabine, with or without Systemic Intravenous Bevacizumab [ Time Frame: First 21 day cycle ]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• Psilocybin in Cancer Pain Study
  PHASE2 · Recruiting · Yvan Beaussant, MD, MSci · Boston, Massachusetts