Intraperitoneal Oxaliplatin for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Carcinoma+1 More
Intraperitoneal Oxaliplatin - Drug
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a new chemotherapy regimen can be used to treat patients with peritoneal carcinomatosis.

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Eligible Conditions

  • Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Intraperitoneal Oxaliplatin will improve 5 primary outcomes in patients with Carcinoma. Measurement will happen over the course of 30 days after completion of treatment (estimated to be 22 weeks).

Week 22
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
Year 8
To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after surgical debulking and peritoneal scan documenting functional of intraperitoneal ports in patients with peritoneal carcinomatosis
Week 30
Progression rate
Year 5
Overall survival
Progression-free survival (PFS)

Trial Safety

Trial Design

5 Treatment Groups

Dose Level 4
1 of 5
Dose Level 2
1 of 5
Dose Level 3
1 of 5
Dose Level 1
1 of 5
Dose Level 5
1 of 5
Experimental Treatment

This trial requires 21 total participants across 5 different treatment groups

This trial involves 5 different treatments. Intraperitoneal Oxaliplatin is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose Level 4
Drug
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.
Dose Level 2Intraperitoneal 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.
Dose Level 3Intraperitoneal 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.
Dose Level 1Intraperitoneal 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.
Dose Level 5Intraperitoneal 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Capecitabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completion of enrollment (approximately 8 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly completion of enrollment (approximately 8 years) for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A peritoneal scan is a diagnostic test that uses images of the abdomen to look for problems such as cancer, infection, or bleeding show original
All patients must be aware of the risks and benefits of chemotherapy prior to receiving treatment show original
People who want to receive chemotherapy must have had surgery to remove any large tumors, and must have healed for at least four weeks before starting chemo. show original
A port may be placed during or at any time separate from surgical debulking show original
Patients must have fully recovered from any uncontrolled intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmias. show original
Some patients may have received chemotherapy prior to their surgery. show original
This means that the absolute neutrophil count must be at least 1,500/mm³. show original
Patients must have a cancer that has spread to the lining of their stomach (the peritoneum) from either their colon or appendix. show original
Patients must be at least 18 years old in order to be treated with oxaliplatin show original
The person has a very good performance status. show original

Patient Q&A Section

What causes peritoneal neoplasms?

"In about 15% of cases, a peritoneal neoplasm is the sole apparent cause of an ascites in a patient with a previous history of malignancy, a negative search for a local recurrence, and without intra-thoracic metastases. Further, about 15% of patients with peritoneal neoplasms develop ascites and then relapse, whereas others develop this symptom, which may be a clue to the diagnosis of neoplasm, even before the detection of an intra-thoracic metastasis." - Anonymous Online Contributor

Unverified Answer

What is peritoneal neoplasms?

"The epidemiology of peritoneal neoplasms differs from those of other areas of the body, mainly due to an increased prevalence of appendices, bowel neoplasms and adenocarcinomas." - Anonymous Online Contributor

Unverified Answer

What are common treatments for peritoneal neoplasms?

"There are many treatments used in the treatment of peritoneal neoplasms but the predominant treatment is surgery. There is a need for a systematic review to determine the optimum treatments in the current times of increasing use of other, not yet established, therapies." - Anonymous Online Contributor

Unverified Answer

What are the signs of peritoneal neoplasms?

"As there are many possible causes to account for abdominal pain, diagnosis of peritoneal neoplasms can be difficult to definitively identify. Although there are some possible signs to look for, it is not possible to definitively rule out all causes of abdominal pain." - Anonymous Online Contributor

Unverified Answer

How many people get peritoneal neoplasms a year in the United States?

"About 4.5 million men with peritoneal neoplasms are diagnosed each year in the United States. Most are diagnosed among whites with early-onset disease. The overall 5-year survival rate is about 80%." - Anonymous Online Contributor

Unverified Answer

Can peritoneal neoplasms be cured?

"Results from a recent paper, of the 30 patients who underwent resection, 18 (57%) were able to return to life after surgery but 8 of the 30 (23%) died. For both groups, the 1-year survival rate was 70% (S + E, 100%). For patients treated surgically, it is difficult to determine whether an increased survival time was due to the surgery or from some other cause of death. Results from a recent paper are consistent with a large series of surgeons who had previously reported similar results after curative surgical resection of peritoneal carcinomatosis." - Anonymous Online Contributor

Unverified Answer

What is the latest research for peritoneal neoplasms?

"[Currently, no studies have been done about the use of anti-PD-1/PD-L1 inhibitors and PD-1/PD-L1 pathway inhibitors in this type of cancer.] Ipilimumab showed a potent immunostimulatory function and a low toxicity profile. Anti-PD-1/PD-L1 antibodies showed a strong antitumor activity. Targeted therapies are an option for patients with peritoneal neoplasms, but the identification of molecular pathways to regulate and prevent tumors is needed." - Anonymous Online Contributor

Unverified Answer

How serious can peritoneal neoplasms be?

"Peritoneal neoplasms are rare and are more common in older patients. Although most neoplasms are benign, there are also malignant peritoneal neoplasms; moreover, 5 out of 7 cancers are related to other forms of cancer. Peritoneal neoplasms are a challenging group to treat because of the difficulty in obtaining an appropriate resection, the possibility of tumour recurrence and metastasis, and incomplete knowledge of the treatment options. A complete surgical resection is often not possible especially with small, low-grade lesions. Because of the rarity of peritoneal neoplasms and the heterogeneity of the surgical approaches, it is important to develop specific protocols for peritoneal oncological surgery." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of intraperitoneal oxaliplatin?

"Oxaliplatin-induced side effects are frequent, disabling, and of considerable concern for the patients. The most common toxicity is nephrotoxicity and, accordingly, oxaliplatin should be administered in adequate doses over short periods." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for peritoneal neoplasms?

"The following two criteria were identified as most important to include in a clinical trial for peritoneal cancer: 1) a well-defined study population; 2) an indication where surgery or laparotomy plus adjuvant chemotherapy is the sole therapy. We conclude that a clinical trial of peritoneal cancer should be considered when the following is true: 1) the population is well-defined; 2) there is direct proof of an interaction between a surgical intervention and a chemotherapy/adjuvant-chemotherapy; or 3) the population seems to be sufficiently ill that survival benefits are to be expected." - Anonymous Online Contributor

Unverified Answer

What is intraperitoneal oxaliplatin?

"Oxaliplatin was well-tolerated during this pilot study. Iintraperitoneal chemotherapy with oxaliplatin offers the potential to improve the long-term prognosis of platinum-refractory and platinum-sensitive peritoneal malignancies." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in intraperitoneal oxaliplatin for therapeutic use?

"Many new methods for the treatment of peritoneal cancer have been recently introduced. The use of oxaliplatin has been an option in this respect. However, the use of oxaliplatin in peritoneal cancer is an alternative only under the following circumstances: in combination with the following agents: cisplatin, and if it is necessary to administer more than a 1,000 mg/m3 dose of oxaliplatin. In patients which present a good condition, there are no significant side-effects, so that it can be used alone or combined with cisplatin." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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