A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00585533
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 93
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.

Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Erlotinib (Tarceva)	Phase 2

Detailed Description

Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC

Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: A	Drug: Erlotinib (Tarceva); Erlotinib; Other Names: Tarceva

Outcome Measures

Primary Outcome Measures

1. Survival Rate at 6-months Chemotherapy-progression-free (CP-free) [6 months]

   Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.

Secondary Outcome Measures

1. Overall Survival [24 months]

   Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Performance status 0-1.

• Weight Loss < 10% in preceding 3 months

• Age 18 years and older.

• Adjuvant chemotherapy allowed if > 6 months from protocol entry

• Adequate Organ Function

• Liver enzymes < 2X normal, bilirubin = normal

• Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)

• Creatinine <2.0 mg

Exclusion Criteria:

• Not pregnant or lactating.

• No Clinical Brain Metastases

• No prior chemotherapy for systemic disease

• Imminent need for chemotherapy for impending organ dysfunction is not allowed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Wallace Akerley, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT00585533
• Other Study ID Numbers: HCI12555; IRB# 00012555; NCT00204724
• First Posted: Jan 3, 2008
• Last Update Posted: Jul 30, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Lung Neoplasms; Erlotinib Hydrochloride

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	All participants enrolled in trial.
Period Title: Overall Study
STARTED	40
COMPLETED	31
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants enrolled in trial.
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 25%
>=65 years	30 75%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (10.09443)
Sex: Female, Male (Count of Participants)
Female	15 37.5%
Male	25 62.5%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
Description	Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	All participants enrolled in trial.
Measure Participants	40
Number [percentage of participants]	55 137.5%

2. Secondary Outcome

Title	Overall Survival
Description	Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	All participants enrolled in trial.
Measure Participants	40
Median (95% Confidence Interval) [weeks]	50.1

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	All participants enrolled in trial.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	9/40 (22.5%)
Gastrointestinal disorders
Diarrhea	2/40 (5%)	2
General disorders
Deep Vein Thrombosis	1/40 (2.5%)	1
Metabolism and nutrition disorders
Mucositis	1/40 (2.5%)	1
Skin and subcutaneous tissue disorders
Rash	3/40 (7.5%)	3
Paronychia	2/40 (5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.