Chemotherapy delivered directly to abdomen shows promise in early trial
NCT ID NCT01061515
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
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21 people
The number who actually took part.
- Started
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May 2011
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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