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Monoclonal Antibodies

Chemotherapy + Bevacizumab for Abdominal Cancer

Phase 1

Waitlist Available

Led By Benjamin Tan, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatic function: Total bilirubin must be <2X the institutional upper limit of normal (ULN), Transaminases (SGOT and/or SGPT) must be ≤3X the institutional upper limit of normal (ULN), Alkaline phosphatase must be ≤4X the institutional upper limit of normal (ULN)

Renal Function: Patients must have adequate renal function prior to chemotherapy defined as serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥60 ml.min/1.73 m² for patients with creatinine levels above 2.0 mg/dl

Must not have

Gastrointestinal ailments that may alter the absorption of oral medications (i.e. bowel obstruction, short-gut syndrome)

Patients with Grade 2 or higher peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining two drugs, one given directly into the abdomen and one taken by mouth. It is for people with a certain kind of cancer that has spread into the abdomen, and who have had surgery to remove as much of the cancer as possible.

Who is the study for?

This trial is for adults with peritoneal carcinomatosis from colorectal or appendiceal cancer, who've had debulking surgery and have a working intraperitoneal port. They should be ECOG 0-2, recovered from major illnesses, not pregnant or breastfeeding, and without severe neuropathy or allergies to the drugs tested.

What is being tested?

The study tests escalating doses of Oxaliplatin given directly into the abdomen in combination with Bevacizumab and Capecitabine taken systemically. It's for patients post-surgery showing clear pathways in their abdominal ports.

What are the potential side effects?

Potential side effects include nerve damage (neuropathy), allergic reactions, bleeding issues due to low platelets, fatigue from anemia or high bilirubin levels, liver enzyme elevations indicating liver stress, and kidney function impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver tests are within the required limits.

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My kidney function is good enough for chemotherapy.

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My cancer in the lining of my abdomen comes from colon or appendix cancer.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any stomach or bowel problems that affect how I absorb pills.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression rate

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Dose Level 5Experimental Treatment3 Interventions

Intraperitoneal oxaliplatin 100 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine PO BID on days 1-7 of each cycle. Each cycle is 14 days long.

Group II: Dose Level 4Experimental Treatment1 Intervention

Intraperitoneal oxaliplatin 85 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine PO BID on days 1-7 of each cycle. Each cycle is 14 days long.

Group III: Dose Level 3Experimental Treatment3 Interventions

Intraperitoneal oxaliplatin 65 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine PO BID on days 1-7 of each cycle. Each cycle is 14 days long.

Group IV: Dose Level 2Experimental Treatment3 Interventions

Intraperitoneal oxaliplatin 50 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine PO BID on days 1-7 of each cycle. Each cycle is 14 days long.

Group V: Dose Level 1Experimental Treatment3 Interventions

Intraperitoneal oxaliplatin 25 mg/m2 IP on day 1 of each cycle Bevacizumab 5 mg/kg CIVI on day 1 of each cycle Capecitabine PO BID on days 1-7 of each cycle. Each cycle is 14 days long.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Intraperitoneal Oxaliplatin

2015

Completed Phase 2

~60