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Gastrointestinal CancerPhase 2NCT00353015

Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

A Phase 2 study testing Cisplatin and Irinotecan in people with Gastrointestinal Cancer and Carcinoma, Neuroendocrine, run by M.D. Anderson Cancer Center 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

Primary Objective: 1. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract. Secondary Objective: 1. Read more about this study

Who is it for?
Any age
What is being tested?
Cisplatin and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Mar 2003to Jul 2009
Phase
Phase 2
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

Who may be able to join

  • Histologic diagnosis of high grade (poorly differentiated, small cell) gastrointestinal neuroendocrine carcinoma.
  • High grade neuroendocrine carcinoma of unknown primary site (if a pulmonary primary has been excluded).
  • Metastatic or unresectable disease.
  • Measurable disease.
  • Informed consent.
  • Zubrod performance status of 0 or 1.
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  • Adequate bone marrow function (defined as absolute neutrophil count [ANC] >= 1500, platelet count [PLT] >= 100,000 and a hemoglobin [Hgb] >= 10).
  • Adequate hepatic function with a bilirubin of <= 2.0 mg/dl, and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <= 2.5 times the upper limits of normal, unless caused by liver metastasis. If caused by metastasis, then should be SGPT and SGOT <= 5 times the upper limits of normal.
  • Adequate renal function defined as serum creatinine <= 1.5 mg/dl.
  • Fertile patients and their partners must practice appropriate contraceptive methods while on study.
  • Recovered from recent surgery. One week must have elapsed from the time of a minor surgery and 3 weeks from major surgery.

Who cannot join

  • Patients with prior systemic chemotherapy are ineligible.
  • Other concurrent chemotherapy, immunotherapy, or radiotherapy.
  • Patients with brain metastases are not eligible. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible.
  • Patients with New York Heart Association (NYHA) Class III or IV heart disease are not eligible as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
  • Pregnant or lactating women. All women of child bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
  • Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, are ineligible.
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  • Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol are ineligible.
  • Patients with serum calcium > 12 mg/dl or symptomatic hypercalcemia under treatment are ineligible.
  • Patients with osseous metastasis as only site of disease.
  • Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
  • Patients with known Gilbert's syndrome are ineligible.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • U.T. M.D. Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

Primary Objective:

  1. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.

Secondary Objective:

  1. To assess the safety profile of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.
Read the detailed description

Both irinotecan and carboplatin are drugs commonly used to treat cancer.

Before treatment starts, patients will have blood tests (around 4 teaspoons) and urine tests. Patients will have a chest X-ray, an electrocardiogram (ECG-a test to measure the electrical activity of the heart), and a computed tomography (CT) scan. Women who are able to have children must have a negative blood pregnancy test.

During the study, patients will receive irinotecan and cisplatin by vein over 4 hours, once a week for 2 weeks. This will be followed by 7 days in which no treatment will be given. This 3 week period is called a cycle. Cycles will be repeated unless the tumor continues to grow.

During treatment, patients will have follow-up visits every 3 weeks to check for any side effects and the status of the disease. The follow-up visits may be with either your local doctor or with the study doctor. However, visits with the study doctor should be scheduled at least every 9 weeks. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study.

This is an investigational study. Both irinotecan and cisplatin are FDA approved and commercially available. Around 36 patients will participate in the study. All patients will be enrolled at M.D. Anderson.

Being tested
Cisplatin, Irinotecan
Keywords
Gastrointestinal cancer, high grade gastrointestinal neuroendocrine carcinoma, High grade neuroendocrine carcinoma of unknown primary site, Cisplatin, Platinol-AQ, Platinol, CDDP, CPT-11, Irinotecan
Medical subject headings
Gastrointestinal Neoplasms, Carcinoma, Neuroendocrine

What participants receive

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

  • CisplatinDrug

    Also called Platinol-AQ, Platinol, CDDP

    Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle

  • IrinotecanDrug

    Also called CPT-11

    Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle

Study groups in NCT00353015
Study groupRoleWhat they receive
Irinotecan plus CisplatinExperimentalIrinotecan 65 mg/m2 and Cisplatin 25 mg/m2 intravenous (IV) days 1, 8 of a 21-day cycle
Receives: Drug: Cisplatin; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Response Rate of Irinotecan and Cisplatin

    Clinical activity defined by number of participants with Complete Response (CR) and Partial Response (PR) divided by total number of particpants using Response Evaluation Criteria in Solid Tumors (RECIST) where changes in tumor measurements confirmed by repeat assessments no less than 4 weeks after criteria for CR and PR responses first met.

    Measured: Every 3 weeks

Timeline

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

  1. First posted17 Jul 2006 (estimated)
  2. Study startMar 2003
  3. Primary completionDec 2007
  4. Study completionJul 2009

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00353015
Sponsor's protocol ID
ID02-523
Status last verified
Aug 2012
First submitted
13 Jul 2006
Last updated
2 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin and Irinotecan in people with Gastrointestinal Cancer and Carcinoma, Neuroendocrine, run by M.D. Anderson Cancer Center at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Participant Response Rate of Irinotecan and Cisplatin (time frame: Every 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00353015.

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 2 Aug 2012.

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