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Lung CancerPhase 2NCT00193375

Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

A Phase 2 study testing Irinotecan, Carboplatin and Bevacizumab in people with Lung Cancer, run by SCRI Development Innovations, LLC.

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

In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Irinotecan, Carboplatin and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Aug 2003to May 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • To be included in this study, you must meet the following criteria:
  • Small cell lung cancer, confirmed by biopsy.
  • Limited stage disease after standard evaluation.
  • Able to perform activities of daily living without assistance.
  • No previous treatment with chemotherapy, radiation therapy, or biologics.
  • Measurable or evaluable disease
  • Adequate bone marrow, liver and kidney function
  • Able to understand the nature of this study and give written consent.

Who cannot join

  • You cannot participate in this study if any of the following apply to you:
  • Age < 18 years
  • History of previous malignancies
  • Women pregnant or lactating
  • History or physical exam evidence of central nervous system disease)
  • Active infection requiring intravenous antibiotics
Show all 15Show fewer
  • Full-dose anticoagulation or thrombolytic therapy within 10 days
  • Proteinuria.
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence if bleeding diathesis or coagulopathy
  • History of heart attack within 6 months.
  • Uncontrolled cardiovascular disease
  • PEG or G-tube
  • History of other serious disease
  • Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

About this study

Official title: Phase II Trial of Concurrent Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab (Avastin) in the Treatment of Patients With Limited Stage Small Cell Lung Cancer

In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.

Read the detailed description

Upon determination of eligibility, all patients will be receive:

  • Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab

Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.

Conditions
Lung Cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • IrinotecanDrug

    Also called Camptosar

    50mg/m2 days 1 \& 8 each 21-day cycle 1 \& 2, 28-day cycle 3 \& 4

  • CarboplatinDrug

    Also called Paraplatin

    AUC 5

  • BevacizumabDrug

    Also called Avastin

    10mg/kg IV every 2 weeks for 10 doses starting week 16

  • RadiationRadiation

Study groups in NCT00193375
Study groupRoleWhat they receive
InterventionExperimentalPatients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
Receives: Drug: Irinotecan; Drug: Carboplatin; Drug: Bevacizumab; Radiation: Radiation

What is being measured

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

  1. Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)

    Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.

    Measured: 18 months

Secondary outcomes (2)

  1. 2-Year Progression-free Survival (PFS)

    Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.

    Measured: 24 months

  2. Overall Response Rate

    Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

    Measured: 18 month

Timeline

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

  1. First posted19 Sep 2005 (estimated)
  2. Study startAug 2003
  3. Primary completionApr 2008
  4. Study completionMay 2008

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00193375
Sponsor's protocol ID
SCRI LUN 72
Status last verified
Jun 2016
First submitted
12 Sep 2005
Last updated
10 Aug 2016
Data monitoring committee
No

Publications

  • Spigel DR, Greco FA, Zubkus JD, Murphy PB, Saez RA, Farley C, Yardley DA, Burris HA 3rd, Hainsworth JD. Phase II trial of irinotecan, carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2009 Dec;4(12):1555-60. doi: 10.1097/JTO.0b013e3181bbc540.

    PubMed 19875975

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan, Carboplatin and Bevacizumab in people with Lung Cancer, run by SCRI Development Innovations, LLC.

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 8 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 13 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC) (time frame: 18 months). 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 NCT00193375, which also lists 1 linked publication.

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 10 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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