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Monoclonal Antibodies

Chemotherapy + Bevacizumab for Abdominal Cancer

Q: Has the Federal Drug Administration sanctioned Intraperitoneal Oxaliplatin?

The clinical risk of Intraperitoneal Oxaliplatin is rated as a 1 on the scale due to this being an early-stage trial, which has limited evidence supporting its safety and efficacy.

Q: For which medical conditions is Intraperitoneal Oxaliplatin prescribed?

Intraperitoneal Oxaliplatin has demonstrated efficacy in treating recurrent platinum-resistant epithelial <a href="https://www.withpower.com/clinical-trials/ovarian-cancer">ovarian cancer</a> as well as other malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and locally advanced nonsquamous non-small cell lung cancers.

Q: Have other trials been conducted with Intraperitoneal Oxaliplatin treatments?

Currently, 842 trials are actively pursuing the efficacy of Intraperitoneal Oxaliplatin in 260 Phase 3 studies. The majority of these research initiatives have a presence in Guangzhou, Guangdong; however, 34254 medical sites across the globe are participating.

Q: What is the upper limit for participation in this experiment?

This clinical trial has suspended its search for participants as of 11/10/2022. If you are looking to join a different medical study, there are presently 2509 trials enrolling patients with carcinoma and 842 studies that require Intraperitoneal Oxaliplatin volunteers.

Q: Is enrollment still open for this trial?

The information provided on clinicaltrials.gov indicates that this trial is not currently recruiting participants, as it was first posted in May 2011 and last updated November 2022. Despite the study's closure to enrollment, there are a plethora of other studies which remain open for recruitment at the moment with 3351 options available.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of enrollment (approximately 8 years)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of enrollment (approximately 8 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of enrollment (approximately 8 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of enrollment (approximately 8 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the safety and tolerability of IP oxaliplatin and intravenous (i.v.) bevacizumab and oral capecitabine after surgical debulking and functional intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology

Overall survival

Progression rate

+2 more

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

Capecitabine

2013

Completed Phase 3

~3420

Intraperitoneal Oxaliplatin

2015

Completed Phase 2

~60

Bevacizumab

2013

Completed Phase 4

~5280

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,688 Total Patients Enrolled

Benjamin Tan, M.D.Principal InvestigatorWashington University School of Medicine

5 Previous Clinical Trials

287 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01061515 — Phase 1

Cancer Research Study Groups: Dose Level 4, Dose Level 3, Dose Level 2, Dose Level 1, Dose Level 5

Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01061515 — Phase 1

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01061515 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration sanctioned Intraperitoneal Oxaliplatin?

"The clinical risk of Intraperitoneal Oxaliplatin is rated as a 1 on the scale due to this being an early-stage trial, which has limited evidence supporting its safety and efficacy."

Answered by AI

For which medical conditions is Intraperitoneal Oxaliplatin prescribed?

"Intraperitoneal Oxaliplatin has demonstrated efficacy in treating recurrent platinum-resistant epithelial ovarian cancer as well as other malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and locally advanced nonsquamous non-small cell lung cancers."

Answered by AI

Have other trials been conducted with Intraperitoneal Oxaliplatin treatments?

"Currently, 842 trials are actively pursuing the efficacy of Intraperitoneal Oxaliplatin in 260 Phase 3 studies. The majority of these research initiatives have a presence in Guangzhou, Guangdong; however, 34254 medical sites across the globe are participating."

Answered by AI

What is the upper limit for participation in this experiment?

"This clinical trial has suspended its search for participants as of 11/10/2022. If you are looking to join a different medical study, there are presently 2509 trials enrolling patients with carcinoma and 842 studies that require Intraperitoneal Oxaliplatin volunteers."

Answered by AI

Is enrollment still open for this trial?

"The information provided on clinicaltrials.gov indicates that this trial is not currently recruiting participants, as it was first posted in May 2011 and last updated November 2022. Despite the study's closure to enrollment, there are a plethora of other studies which remain open for recruitment at the moment with 3351 options available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer

2011. "Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01061515.

All > Peritoneal Carcinomatosis > Rectal Cancer