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Carcinoma, Non-Small-Cell LungPhase 2NCT00352690

A Phase II Study of Radiation Therapy, Paclitaxel Poliglumex, and Carboplatin in Stage III Non-Small Cell Lung Cancer

A Phase 2 study testing Paclitaxel poliglumex, Carboplatin and External beam radiation therapy in people with Carcinoma, Non-Small-Cell Lung, run by Washington University School of Medicine at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Paclitaxel poliglumex, Carboplatin and External beam radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
8 sitesUnited States
Study dates
Apr 2006to Jun 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

  • Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas).
  • Eligible Disease Stages: Inoperable IIIA and Selected IIIB
  • Local radiation oncologist must approve patient eligibility prior to entry on study.
  • Patients must have measurable disease.
  • Prior Therapy:
  • ≥ 2 weeks since formal exploratory thoracotomy.
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  • No prior chemotherapy or radiation therapy for NSCLC.
  • ECOG performance status 0-1
  • Required Initial Laboratory Values (must be submitted within 16 days prior to registration):
  • Granulocytes ≥ 1,500/µl
  • Platelets ≥ 100,000/µl
  • Calculated Creatinine Clearance ≥ 20 cc/min
  • Bilirubin < 1.5 mg/dl
  • AST (SGOT) < 2 x ULN
  • INR > 0.8 < 1.2* *Values apply exclusively to patients not being treated with warfarin. Values for patients being treating with warfarin should fall within the following therapeutic range: > 2.0 < 3.0.

Who cannot join

  • Currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
  • Pregnant or nursing because of significant risk to the fetus/infant.
  • Age <18 years.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • No HIV-positive patients receiving combination anti-retroviral therapy. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy
  • One-second forced expiratory volume (FEV1) <50% or hemoglobin-corrected carbon monoxide diffusion capacity (DLCO) <50% of predicted, as measured within 21 days of study entry
  • Symptoms of esophageal dysfunction (dysphagia, odynophagia, or inability to swallow solid food) within 4 weeks prior to study randomization. Patients must not require prophylactic placement of percutaneous enterogastrostomy (PEG) tube or other non-oral nutritional supplement methods
  • Weight loss of > 10% in the past 3 months.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Rush University Medical College

    Chicago, Illinois

  • University of Missouri, Columbia

    Columbia, Missouri, 65211

  • University of Kansas

    Lawrence, Kansas, 66045

  • University of Minnesota, Twin Cities

    Minneapolis, Minnesota

  • University of California, San Francisco

    San Francisco, California, 94143

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.

Being tested
Paclitaxel poliglumex, Carboplatin, External beam radiation therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Paclitaxel poliglumexDrug

    Also called Xyotax

  • CarboplatinDrug

    Also called Paraplatin

  • External beam radiation therapyRadiation

Study groups in NCT00352690
Study groupRoleWhat they receive
Cohort 1 (first 12 eligible patients)OtherPaclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Receives: Drug: Paclitaxel poliglumex; Drug: Carboplatin; Radiation: External beam radiation therapy
Cohort 2 (remaining patients)ExperimentalPaclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Receives: Drug: Paclitaxel poliglumex; Drug: Carboplatin; Radiation: External beam radiation therapy

What is being measured

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

  1. Overall Survival (OS) Rate

    • OS = time from patient registration to death of all causes
    • Estimated using Kaplan Meier

    Measured: 6 months

  2. Overall Survival (OS)

    OS = time from patient registration to death of all causes

    Measured: Completion of follow-up (follow-up ranged from 3 months to 6 years)

Secondary outcomes (5)

  1. Failure-free Survival (FFS) Rate

    • The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)
    • Estimated using Kaplan Meier

    Measured: 6 months

  2. Failure-free Survival (FFS)

    The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)

    Measured: Completion of follow-up (follow-up ranged from 3 months to 6 years)

  3. Response Rates

    Overall best response using RECIST 1.0

    Measured: 4 years

  4. Incidence and Severity of Radiation-induced Esophagitis

    Measured: 30 days following completion of treatment (approximately 114 days)

  5. Incidence and Severity of Radiation-induced Pneumonitis

    Measured: 30 days following completion of treatment (approximately 114 days)

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 startApr 2006
  3. Primary completionJun 2008
  4. Study completionJun 2008

Why it stopped: Safety of patients

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
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352690
Sponsor's protocol ID
05-1195
Status last verified
Oct 2016
First submitted
14 Jul 2006
Last updated
12 Dec 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel poliglumex, Carboplatin and External beam radiation therapy in people with Carcinoma, Non-Small-Cell Lung, run by Washington University School of Medicine at 8 sites 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 15 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

Yes. Results are posted in the registry (first posted 27 May 2015). 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?

Overall Survival (OS) Rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00352690.

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 12 Dec 2016.

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