NCT00005838|CompletedPhase 3

Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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4 other identifiers

NCI-2012-02725ID99-303U10CA045809CDR0000067853

Study Type

interventional

Target

756

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedMar 2000

Brief Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without AE-941 for non-small cell lung cancer. This randomized phase III trial is studying combination chemotherapy and radiation therapy given with AE-941 to see how well they work compared to combination chemotherapy and radiation therapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

756

participants targeted

Target at P75+ for phase_3

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed

2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed

Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

6.9 years

First QC Date

June 2, 2000

Last Update Submit

January 22, 2013

Conditions

Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Large Cell Lung Cancer Squamous Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Overall survival
Survival distributions will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted to illustrate the comparative survival experience of both groups over the entire study period.
From randomization until date of death or last follow-up, assessed up to 7 years

Secondary Outcomes (4)

Progression-free survival every 3 months
From randomization until disease progression, assessed up to 7 years
Tumor response rate
Up to 7 years
Tumor response duration
From first observation of at least a partial response to detection of disease progression or death due to any cause, assessed up to 7 years
Metastasis-free survival
From randomization until metastasis documented by imaging procedures, assessed up to 7 years

Study Arms (2)

Arm I (shark cartilage extract AE-941)

EXPERIMENTAL

Patients receive oral AE-941 (Neovastat) twice daily beginning on day 1 or within 10 days of initiation of chemotherapy. All patients receive induction chemotherapy with 1 of the following platinum-based regimens: cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85. All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms continues in the absence of unacceptable toxicity.

Drug: shark cartilage extract AE-941Drug: cisplatinDrug: vinorelbine tartrateDrug: carboplatinDrug: paclitaxelRadiation: radiation therapy

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive oral placebo twice daily beginning on day 1 or within 10 days of initiation of chemotherapy. All patients receive induction chemotherapy with 1 of the following platinum-based regimens: cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85. All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms continues in the absence of unacceptable toxicity.

Other: placeboDrug: cisplatinDrug: vinorelbine tartrateDrug: carboplatinDrug: paclitaxelRadiation: radiation therapy

Interventions

shark cartilage extract AE-941DRUG

Given orally

Also known as: AE-941, Neovastat, Neovastat/AE-941

Arm I (shark cartilage extract AE-941)

placeboOTHER

Given orally

Also known as: PLCB

Arm II (placebo)

cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP