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Chemotherapy delivered directly to abdomen shows promise in early trial

NCT ID NCT01061515

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This early-phase trial tests a combination of three drugs for people whose appendix or colon cancer has spread to the lining of the abdomen (peritoneal carcinomatosis). After surgery to remove visible tumors, patients receive chemotherapy directly into the abdomen (oxaliplatin) plus oral and intravenous drugs (capecitabine and bevacizumab). The main goal is to find the safest dose and check for side effects in 21 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxaliplatin (chemotherapy), capecitabine (chemotherapy), bevacizumab (targeted therapy)
What this could lead to
If this works, it could point toward a more effective way to deliver chemotherapy directly to the abdomen for people with advanced abdominal cancers, potentially improving survival.
What could go wrong
This is a very early (Phase 1) trial with only 21 participants, so it is primarily testing safety and dosing, not effectiveness. The combination may cause significant side effects, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

May 2011

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological Diagnosis: Patients must have a histologically documented peritoneal carcinomatosis from either colorectal or appendiceal adenocarcinoma. * Prior Surgical Debulking: Patients must have undergone debulking surgery with peritonectomy and have been allowed at least 4 weeks to recover prior to receiving chemotherapy. * Port Placement: Intraperitoneal ports may be placed during or at any time separate from surgical debulking. Provided the patient has been allowed at least 4 weeks to recover from surgical debulking, no additional recovery time is required for port placement. * Active port: Patients must undergo a peritoneal scan documenting at least one working intraperitoneal port prior to receiving chemotherapy. * Patients may have received prior chemotherapy. * Age: Patients must be ≥18 years of age. Because no dosing or toxicity data are currently available on the use of oxaliplatin in patients \<18 years of age. * Performance Status: (Eastern cooperativeOncology Group) ECOG 0-2. * Recovery from Intercurrent Illness: Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmias. * Informed Consent: All patients must be consented prior to chemotherapy. The patient should not have any serious medical of psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. * Hematological Status: * absolute neutrophil count ≥1,500/mm³ * platelet count ≥100,000/mm³ * hemoglobin ≥8 g/dl. * 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. Exclusion Criteria: * Pregnant or breast feeding: For all sexually active patients, the use of adequate contraception (hormonal or barrier method of birth control) will be required during therapy, prior to study entry, and for the duration of study participation. Non-pregnant status will be determined in all women of childbearing potential. * Prior history of hypersensitivity reactions to oxaliplatin, bevacizumab, 5-FU or capecitabine. * Gastrointestinal ailments that may alter the absorption of oral medications (i.e. bowel obstruction, short-gut syndrome). * Patients receiving antiretroviral therapy Highly Active Anti Retroviral Treatment (HAART) for HIV infection are excluded from the study because of possible pharmacokinetic interactions. Appropriate studies will be undertaken in patients receiving HAART therapy, when indicated. * Patients with Grade 2 or higher peripheral neuropathy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.