STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCERPhase 1/2NCT01757288

Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC

A Phase 1/2 study testing NAB-PACLITAXEL and PACLITAXEL in people with STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER, run by University of Texas Southwestern Medical Center at 5 sites 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

Who is it for?: Ages 18 to 99 years
Conditions the study is for: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
What is being tested?: NAB-PACLITAXEL and PACLITAXEL
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 5 sitesUnited States
Study dates: 25 Mar 2013to 3 Jun 2019
Phase: Phase 1/2
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume.
Patients with Zubrod performance status 0-1
Adequate hematologic function
FEV1 with ≥ 1200 cc or ≥ 50% predicted

Who cannot join

Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
Exudative, bloody, or cytologically malignant effusions
Prior therapy with any molecular targeted drugs (for lung cancer)
Active pulmonary infection not responsive to conventional antibiotics
Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
Patients with > grade 1 neuropathy

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Texas Southwestern Medical Center
Dallas, Texas, 75239
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

Official title: A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)

The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with carboplatin concurrent with daily radiation.

Conditions: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Being tested: NAB-PACLITAXEL, PACLITAXEL
Keywords: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
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.

NAB-PACLITAXELDrug
Also called Abraxan
nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
PACLITAXELDrug
NAB-PACLITAXELDrug
Also called Abraxan
nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks

Study groups in NCT01757288
Study group	Role	What they receive
PACLITAXEL (Phase II, Arm A)	Active comparator	PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Receives: Drug: PACLITAXEL
NAB-PACLITAXEL (Phase II, Arm B)	Experimental	NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Receives: Drug: NAB-PACLITAXEL
NAB-PACLITAXEL (Phase I)	Experimental	NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Receives: Drug: NAB-PACLITAXEL

What is being measured

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

2-year Overall Survival (Phase II)
2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years.
Measured: 2 years

Secondary outcomes (10)

The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy
The feasibility as measured by the number of participants who had grade 3 or higher radiation related esophagitis or pulmonary toxicity or chemotherapy related grade 4 hematological or other non-hematological toxicities occurring within 60 days of the start of treatment; compliance us defined as the completion of the treatment regimen with no more than minor variations.
Measured: 60 days of the start of treatment
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
The objective response rate (ORR) is defined as the percentage of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria
Measured: 1,6,12,18,24 month
Proportion of Participants With Progression-free Survival (Phase II)
Proportion of participants with progression free survival at 2 years is computed as the percentage of participants between randomization and local or regional progression, distant metastases, death, or last known follow-up. Estimates of progression free survival will be calculated using the Kaplan-Meir method.
Measured: 2 years
Median Overall Survival (Phase II)
Median overall survival was based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Measured: every 6 months up to 24 months (approx. 22 months)
EuroQol-5Dimension (EQ-5D) MUS Score at Baseline
EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.
Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."
Measured: Baseline
EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment
EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.
Possible score ranges from 5-25 with higher scores indicating worse outcome. Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."
Measured: End of treatment (6 weeks)
EuroQol-5Dimension (EQ-5D) VAS Score at Baseline
The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.
Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top.
Possible score ranges from 0-100 with higher scores indicating better outcome.
Measured: Baseline
EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment
The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.
Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top.
Possible score ranges from 0-100 with higher scores indicating better outcome.
Measured: End of Treatment (6 weeks)
EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up
The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.
Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top.
Possible score ranges from 0-100 with higher scores indicating better outcome.
Measured: 24 month follow up
EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month
EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.
Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."
Measured: 24 month follow up

Timeline

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

25 Mar 20133 Jun 2019

First posted28 Dec 2012 (estimated)
Study start25 Mar 2013
Primary completion3 Jun 2019
Study completion3 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCERStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01757288
Sponsor's protocol ID: STU 062012-053
Status last verified: Oct 2021
First submitted: 20 Dec 2012
Last updated: 28 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)
ClinicalTrials.gov ID: NCT01757288
Acronym / sponsor ID: STU 062012-053
Conditions: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Keywords: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Celgene
Study start: 25 Mar 2013 (actual)
Primary completion: 3 Jun 2019 (actual)
Study completion: 3 Jun 2019 (actual)
First posted: 28 Dec 2012 (estimated)
Results: Posted 5 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)

Arm	Type	Receives
PACLITAXEL (Phase II, Arm A)	Active comparator	Drug: PACLITAXELPACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
NAB-PACLITAXEL (Phase II, Arm B)	Experimental	Drug: NAB-PACLITAXELNAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
NAB-PACLITAXEL (Phase I)	Experimental	Drug: NAB-PACLITAXELNAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume.
Patients with Zubrod performance status 0-1
Adequate hematologic function
FEV1 with ≥ 1200 cc or ≥ 50% predicted

Key exclusion criteria (6 listed)

Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
Exudative, bloody, or cytologically malignant effusions
Prior therapy with any molecular targeted drugs (for lung cancer)
Active pulmonary infection not responsive to conventional antibiotics
Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NAB-PACLITAXELAlso: Abraxannab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks	Drug	NAB-PACLITAXEL (Phase I)
PACLITAXEL	Drug	PACLITAXEL (Phase II, Arm A)
NAB-PACLITAXELAlso: Abraxannab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks	Drug	NAB-PACLITAXEL (Phase II, Arm B)

Primary outcome

2-year Overall Survival (Phase II)
Time frame: 2 years
2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years.

10 secondary outcomes

The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy
Time frame: 60 days of the start of treatment
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
Time frame: 1,6,12,18,24 month
Proportion of Participants With Progression-free Survival (Phase II)
Time frame: 2 years
Median Overall Survival (Phase II)
Time frame: every 6 months up to 24 months (approx. 22 months)
EuroQol-5Dimension (EQ-5D) MUS Score at Baseline
Time frame: Baseline
EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment
Time frame: End of treatment (6 weeks)
EuroQol-5Dimension (EQ-5D) VAS Score at Baseline
Time frame: Baseline
EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment
Time frame: End of Treatment (6 weeks)
EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up
Time frame: 24 month follow up
EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month
Time frame: 24 month follow up

Results and safety

Results posted to the registry on 5 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NAB-PACLITAXEL (Phase I)	6	6
PACLITAXEL (Phase II, Arm A)	46	38
NAB-PACLITAXEL (Phase II, Arm B)	46	37

Primary outcome: 2-year Overall Survival (Phase II)

Time frame: 2 years. Mean (Full Range). Unit: percentage of participants

Measure	NAB-PACLITAXEL (Phase I) n = 0	PACLITAXEL (Phase II, Arm A) n = 38	NAB-PACLITAXEL (Phase II, Arm B) n = 37
Value	–	66.5 (48.4 to 79.5)	55.5 (36.3 to 71.0)

Population analysed: This outcome was collected for Phase II participants only 2- year overall survival.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NAB-PACLITAXEL (Phase I)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
PACLITAXEL (Phase II, Arm A)	0 of 38 (0%)	38 of 38 (100%)	2 of 38
NAB-PACLITAXEL (Phase II, Arm B)	0 of 37 (0%)	37 of 37 (100%)	3 of 37

Limitations and caveats (from the sponsor): For Quality of life endpoints, we were limited by the log questionnaire completion rate. The number of patients completed quality of life questionnaire ranged from 1-8 patients in each are at month 3,6,9,12. Additionally, there was a high rate of missing data for FACT series questionnaire. As a result, we are reporting EQ-5D result at baseline and end of treatment. The responsible party Dr. Hak Choy has been replaced with the Yuanyuan Zhang as Dr. Choy has left UTSouthwestern Medical Center.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuanyuan Zhang, MD principal investigator

University of Texas Southwestern Medical Center

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NAB-PACLITAXEL and PACLITAXEL in people with STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER, run by University of Texas Southwestern Medical Center at 5 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 5 inclusion and 6 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 combined 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.

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 5 Oct 2021). 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?

2-year Overall Survival (Phase II) (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 NCT01757288.

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 28 Oct 2021.