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Progression Free Survival of the TreatmentPhase 2NCT01480986

IPO-NEC Trial:Study on the Efficacy and Safety Using Sequential IP Therapy and Oct Lar in the Treatment of Advanced GI NEC

A Phase 2 study testing Irinotecan combined with cisplatin, octreotide lar in people with Progression Free Survival of the Treatment, run by Peking University at 1 site in China.

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

This is a prospective, single-armed, open label study on the efficacy and safety of sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the phase one step of the trial, receiving IP therpy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Irinotecan combined with cisplatin, octreotide lar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Sep 2011to Dec 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written Informed consent
  • Male or female patients >=18 years old
  • Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma originating from the GI tract. The grade of the disease is grade 2 or grade 3
  • No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or others. In case the patient received adjuvant therapy after surgery, enrollment is allowed if the adjuvant therapy doesn't contain cisplatin or irinotican and at the same time, the last day of chemotherapy is ≥180 days before screening.
  • Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before enrollment
  • The laboratory parameter meets the following criteria 7 days before enrollment
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  • Hemoglobin ≥90g/L
  • Absolute neutrophil count≥1.5×10^9/L, platelets 100×10^9/L；
  • ALT and AST≤2.5 ULN(in case of the patients with liver metastasis,ALT and AST≤5.0 ULN)
  • ALP ≤2.5 ULN (in case of the patients with liver metastasis,≤5.0 ULN)
  • Total Serum bilirubin ≤1.5 ULN
  • Serum creatinine ≤1.0 ULN
  • KPS ≥70
  • Estimated survival ≥90 days
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment and must be willing to use adequate methods of contraception during the study and for 30 days after last study durg administration.

Who cannot join

  • Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar
  • Any participation in trials simultaneously or 4 weeks before screening.
  • Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
  • Uncontrolled severe diarrhea
  • Unconrolled active infection (fever ≥38 degrees due to infection)
  • severe hepatopathy including active hepatitis and hepatic cirrhosis, renal dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and other chronic systematic diseases.
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  • Chronic treatment with steroids.(In case of the patients with short-term use of steroids, the enrollment is permitted if the administration is stopped 2 weeks before screening.)
  • confirmed or suspected CNS metastasis
  • the history of peripheral nervous system impairment, obvious mental disorder or CNS impairment
  • clinically significant heart disease, including congestive heart failure, symptomatic coronal heart disease, arrythmia uncontrolled by medication and acute myocardial infarction or cardiac insufficiency within 6 months before screening
  • pregnant women or women in lactation period
  • Fertile male or women of child-bearing potential refuse to take highly effective methods of birth control
  • Incidence of other second primary malignant tumors, except for cured basal cell carcinoma and cervical carcinoma in situ.
  • patients of legal incapacity or who have the potential of influence the whole trial due to medical or ethic reasons.
  • Other patients who are not eligible to the trial under investigators' discretion

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tumor Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: a Prospective Study on the Efficacy and Safety Using Sequential Therapy of Irinotecan Combined With Cisplatin (IP)and Octretide Lar in the First Line Treatment of Metastatic or Inoperable Gastrointestinal Poorly Differentiated Neuroendocrine Carcinoma: the IPO-NEC Trial

This is a prospective, single-armed, open label study on the efficacy and safety of sequential IP therapy(Irinotecan plus cisplatin) and octreotide lar in the treatment of GI poorly diffrentiated Neuroendocrine carcinoma. Patient with written consents will enter the phase one step of the trial, receiving IP therpy. Once the IP therapy has been finished without disease progression or progression occurs during the treatment, the patient will enter the phase two step of the trial, receiving octreotide treatment. The primary endpoint is progression free survival in the two steps respectively and secondary endpoint is disease control rate, overall survival and safety

Being tested
Irinotecan combined with cisplatin, octreotide lar

What participants receive

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

  • Irinotecan combined with cisplatin, octreotide larDrug

    Phase 1 irinotecan 180mg/m^2，ivgtt，90min，D1 Cisplatin 50 mg/m^2，ivgtt，120min，D1（with hydration） Phase 2 Octreotide 0.1mg，ih，q8h，D1-14 Octreotide lar 20mg，deep i.m，D8，

Study groups in NCT01480986
Study groupRoleWhat they receive
Treatment armExperimentalThis is a single arm trial. The patient will enter phase one and will continue to phase two once the disease progresses in phase one or the phase one has been completed.
Receives: Drug: Irinotecan combined with cisplatin, octreotide lar

What is being measured

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

  1. Progression Free Survival for Irinotecan plus cisplatin and octreotide

    The primary objective is to investigate the overall progression free suvival for irinotecan plus cisplatin and octretide. The respective PFS of the two treatment steps will also be investigated. The result will be compared with the history treatment outcomes for patients of poorly differentiated neuroendocrine carcinoma.

    Measured: 2 years

Secondary outcomes (3)

  1. Disease control rate

    The second objective includes the disease control rate of irinotecan plus cisplatin and octretide theray.

    Measured: 2 years

  2. Overall survival

    The secondary objective includes the investigation of the overall survival for the patients receiving the sequential treatment of irinotecan plus cisplatin and octretide.

    Measured: 3 years

  3. Safety

    The secondary objective also includes the investigation on the safety profiles of the two interventions, irinotecan plus cisplatin treatment and octretide. The safety profile will be described using incidence of AEs and SAEs, using CTCAE criteria

    Measured: 3 years

Timeline

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

  1. First posted29 Nov 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2012
  4. Study completionDec 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01480986
Sponsor's protocol ID
BJT-NEC-001
Status last verified
May 2015
First submitted
25 Nov 2011
Last updated
19 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan combined with cisplatin, octreotide lar in people with Progression Free Survival of the Treatment, run by Peking University at 1 site in China.

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 15 inclusion and 15 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 19 May 2015. 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 China. 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?

Progression Free Survival for Irinotecan plus cisplatin and octreotide (time frame: 2 years). 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 NCT01480986.

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 19 May 2015.

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