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Peritoneal NeoplasmsPhase 1NCT00001332

Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis

A Phase 1 study testing CHPP with cisplatin in people with Peritoneal Neoplasms and Stomach Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with gastric adenocarcinoma are most frequently diagnosed at an advanced stage. The disease has a marked propensity for loco-regional spread and will be the sole or major site of disease in up to 80% of patients. Various attempts at controlling loco-regional disease have not been successful. Read more about this study

Who is it for?
Any age
Conditions the study is for
Peritoneal Neoplasms, Stomach Neoplasms
What is being tested?
CHPP with cisplatin
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteUnited States
Study dates
Dec 1992to Oct 2000
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Patients age greater than or equal to 18 years.

Patients with histologically proven gastrointestinal adenocarcinoma, mesothelioma, or sarcoma. By standard staging studies there must be evidence of advanced or metastatic intraabdominal disease. Patients with minimal extraabdominal metastatic disease and who have symptoms exclusively referable to advanced intraabdominal malignancy will be considered for the study. Specifically, patients with gastric cancer and bulky N-2 lymph node involvement or patients with other primaries and who have malignant ascites or peritoneal seeding would be considered optimal candidates. If all gross peritoneal disease is resected (i.e., gross omental implants removed by gastrectomy), patients are still eligible for treatment.

Patients must have recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy (30 days).

Patients must not have any significant systemic illness (e.g., infection, cardiovascular, or pulmonary) which would preclude them from being an operative candidate.

patients must have a life expectancy of at least 8 weeks.

Performance status should be ECOG level 0, 1, or 2.

Patients must have adequate renal function (i.e., serum creatinine less than or equal to 2.0 or creatinine clearance of greater than or equal to 45 ml/min).

Patients must be HIV negative.

Women of child bearing age must not be pregnant or breast feeding.

Patients with prior CDDP will be eligible if there is no evidence of existing irreversible CDDP toxicity. Patients suspected of having chronic CDDP toxicity will be further evaluated as clinically indicated.

Patients may have mild elevations (less than 2.0 times normal) in liver function test if the abnormalities are consistent with advanced intra-abdominal cancer.

Abnormalities (greater than 1 sec over normal) in PT or PTT or severe thrombocytopenia (less than 75 K) will render patients ineligible.

A low Hgb secondary to chronic tumor-related, blood loss is acceptable if the patient is willing and able to have transfusion.

Patients will be ineligible if the WBC is less than 3,000.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Cancer Institute (NCI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Patients with gastric adenocarcinoma are most frequently diagnosed at an advanced stage. The disease has a marked propensity for loco-regional spread and will be the sole or major site of disease in up to 80% of patients. Various attempts at controlling loco-regional disease have not been successful. The selective lethal effect of supranormal temperatures on neoplastic cells and the additive or synergistic effect of combining chemotherapy has been well established in laboratory models and has provided the rationale for numerous clinical trials using hyperthermic isolated limb perfusion for advanced extremity melanoma or sarcoma. This Phase I study will evaluate the safety of escalating temperatures of continuous hyperthermic peritoneal perfusion (CHPP) with escalating doses of intraperitoneal Cisplatin (CDDP) in the treatment of patients with advanced peritoneal adenocarcinoma of gastrointestinal origin.

Read the detailed description

Patients with gastric adenocarcinoma are most frequently diagnosed at an advanced stage. The disease has a marked propensity for loco-regional spread and will be the sole or major site of disease in up to 80% of patients. Various attempts at controlling loco-regional disease have not been successful. The selective lethal effect of supranormal temperatures on neoplastic cells and the additive or synergistic effect of combining chemotherapy has been well established in laboratory models and has provided the rationale for numerous clinical trials using hyperthermic isolated limb perfusion for advanced extremity melanoma or sarcoma. This Phase I study will evaluate the safety of escalating temperatures of continuous hyperthermic peritoneal perfusion (CHPP) with escalating doses of intraperitoneal Cisplatin (CDDP) in the treatment of patients with advanced peritoneal adenocarcinoma of gastrointestinal origin.

Being tested
CHPP with cisplatin
Keywords
Cancer Treatment, Chemotherapy, Regional Therapy, Surgery
Medical subject headings
Peritoneal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHPP with cisplatinProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2002 (estimated)
  2. Study startDec 1992
  3. Study completionOct 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001332
Sponsor's protocol ID
930048
Other IDs
93-C-0048
Status last verified
Nov 1999
First submitted
3 Nov 1999
Last updated
4 Mar 2008
Results posted
No

Publications

  • Wisbeck WM, Becher EM, Russell AH. Adenocarcinoma of the stomach: autopsy observations with therapeutic implications for the radiation oncologist. Radiother Oncol. 1986 Sep;7(1):13-8. doi: 10.1016/s0167-8140(86)80120-7.

    PubMed 3775075

  • Eggermont AM, Sugarbaker PH. Efficacy of intracavitary administration of cyclophosphamide, interleukin-2 and lymphokine activated killer cells against established intraperitoneal tumor. Acta Med Austriaca. 1989;16(3-4):47-50.

    PubMed 2609913

  • Knusli C, Ruff P, Laffer U, Stoll HR, Obrist R, Weber W, Obrecht JP. Intraperitoneal chemotherapy in peritoneal malignancy: impact of intensive system care on practicability. Acta Med Austriaca. 1989;16(3-4):70-3.

    PubMed 2692376

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CHPP with cisplatin in people with Peritoneal Neoplasms and Stomach Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001332, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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