← Back to Search

Anti-tumor antibiotic

Nab-Paclitaxel + Paclitaxel + Ramucirumab for Stomach Cancer

Phase 1

Waitlist Available

Led By Yanghee Woo

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Age: ≥ 18 years

The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine must be collected and must demonstrate < 1000mg protein in 24 hours

Must not have

Intolerance to taxanes

History of arterial thromboembolic events such as myocardial infarction (MI), cerebrovascular accident (CVA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new way of delivering chemotherapy directly into the abdominal cavity using a mist (aerosolized) form of nab-paclitaxel. The study will also combine this new

Who is the study for?

This trial is for stomach cancer patients with peritoneal metastases, who are ready to try a combination of treatments. Participants should be suitable for second-line chemotherapy and have not had prior PIPAC or allergic reactions to the drugs used in this study.

What is being tested?

The trial tests nab-paclitaxel PIPAC's safety and optimal dose when combined with paclitaxel and ramucirumab. It evaluates how well these treatments work against stomach cancer that has spread to the abdominal lining.

What are the potential side effects?

Possible side effects include those typical of chemotherapy such as nausea, fatigue, hair loss, nerve damage (neuropathy), and increased risk of infection. Ramucirumab may cause high blood pressure and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

My urine protein levels are low or normal.

Select...

My kidney function, measured by creatinine clearance, is adequate.

Select...

If I have hepatitis C, my viral load is undetectable.

Select...

I am capable of becoming pregnant or fathering a child.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My first cancer treatment, which included drugs like fluorouracil or oxaliplatin, did not work.

Select...

My scans or laparoscopy show cancer spread to the lining of my abdomen.

Select...

My diagnosis is gastric adenocarcinoma confirmed by lab tests.

Select...

I have recovered from side effects of cancer treatment, except for hair loss or hearing loss.

Exclusion Criteria

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

Select...

I cannot tolerate taxane medications.

Select...

I have had a heart attack or stroke.

Select...

I am not pregnant or breastfeeding.

Select...

I am allergic to certain medications similar to those used in this study.

Select...

I have had a previous GI perforation.

Select...

I am on IV nutrition due to a blockage in my intestines.

Select...

I have had or currently have cancer that has spread to my brain.

Select...

I do not have any uncontrolled illnesses like high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Dose-limiting toxicity (DLT)

Secondary study objectives

Functional status

Incidence of post-operative surgical complications

Incidence of treatment-related adverse events (AEs)

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)Experimental Treatment9 Interventions

Patients receive nab-paclitaxel PIPAC IP over 40 minutes on day 1 and SOC paclitaxel IV over 60 minutes on days 15, 22, 29, 43, and 50 and ramucirumab IV over 30-60 minutes on days 15, 29 and 43 of each cycle. Cycles repeat every 8 weeks (56 days) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may then continue SOC paclitaxel IV on days 1, 8, and 15 and ramucirumab IV on days 1 and 15 of each cycle per physician as deemed appropriate. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, tumor biopsy, and CT or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-paclitaxel

2014

Completed Phase 3

~1950

Computed Tomography

2017

Completed Phase 2

~2740