Sunitinib Non Small Cell Lung Cancer Patients Over 70

• Sponsor: US Oncology Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00864721
• Collaborator: Pfizer (Industry)
• Enrollment: 63
• Locations: 13
• Arm: 1
• Duration (Months): 40.9
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Sutent	Phase 2

Detailed Description

In this trial, the activity and tolerability of sunitinib malate (Sutent) will be examined in previously untreated elderly patients (>70 years old) felt not to be candidates for standard cytotoxic chemotherapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Sunitinib Malate in Previously Untreated NSCLC Patients Over the Age of 70
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sunitinib Malate Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.	Drug: Sutent; Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.; Other Names: sunitinib malate

Outcome Measures

Primary Outcome Measures

1. Disease Control Rate (DCR) [Every 6 weeks until progressive disease or death due to any cause, up to 36 month.]

   Disease control rate = CR + PR + SD>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

Secondary Outcome Measures

1. Overall Response Rates (OR) [Every 6 weeks until progressive disease or death due to any causes, up to 36 months.]

   Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

2. Progression-free Survival (PFS) [All patients were followed until progressive disease or death, up to 36 months.]

   PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

3. 1-year Overall Survival (OS) Rate. [All patients were followed until death or up to 36 months.]

   OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.

4. Time to Progression (TTP) [All patients were followed until progressive disease or death, up to 36 months.]

   TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has measurable, metastatic NSCLC, other elderly NSCLC patients over 70 years of age who are not felt to be candidates for standard chemotherapy at the discretion of the treating physician may also be enrolled as long as they meet the criteria; these "special consideration" patients enrollment in the study must be approved by Dr. Reynolds or DR. Smith in Dr. Reynolds absence. Patients must have a nonsquamous histology to be eligible for this study.

• Has not received any prior chemotherapy for the current disease.

• Has an ECOG Performance status. Is 70 years of age or older.Has resolution of all acute toxic effects of radiotherapy or surgical procedures to NCI CTCAE.

• If fertile, patient (males only) has agreed to an acceptable method of birthcontrol to avoid pregnancy for the duration of the study and for a period of 2 months thereafter.

• Has signed the most recent Patient Informed Consent Form. Has signed a Pate int Authorization Form.

Exclusion Criteria:

• Has predominantly squamous NSCLC histology.

• Had prior treatment with study drugs or other drugs.

• Has a history of hypersensitivity to any component of the study drug. Has any evidence of an of antecedent hemoptysis, squamous histology, or ongoing anticoagulation or clotting diathesis.

• Pre-existing hemoptysis Grade 2, cavitating lesions or clear proximity or involvement of blood vessels.

• Has had major surgery or radiation therapy within 4 weeks of starting the study treatment.

• Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the study treatment.

• Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan; however, treated, stable, and asymptomatic brain metastases are allowed.

• Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2.

• Has prolonged QTc interval on baseline EKG. Has uncontrolled hypertension.

• Has pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.

• Is receiving concurrent treatment on another clinical trial.

• Supportive care trials or non-treatment trials, (eg, QOL), are allowed.

• Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy.

• Is receiving concurrent investigational therapy or has received such therapy within the past 30 days.

• Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.

• Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.

• Is unable to comply with requirements of study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocala Oncology Center	Ocala	Florida	United States	34471
2	Cancer Centers of Florida, P.A.	Ocoee	Florida	United States	34761
3	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	United States	55404
4	Cancer Centers of North Carolina	Raleigh	North Carolina	United States	27607
5	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	United States	97401-8122
6	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29605
7	Texas Oncology - Arlington South	Arlington	Texas	United States	76014
8	Texas Oncology, P.A. - Bedford	Bedford	Texas	United States	76022
9	Methodist Charlton Cancer Ctr.	Dallas	Texas	United States	75237
10	Texas Cancer Center of Mesquite	Mesquite	Texas	United States	75150
11	Texas Oncology Cancer Care and Research Center	Waco	Texas	United States	76712
12	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
13	Yakima Valley Mem Hosp/North Star Lodge	Yakima	Washington	United States	98902

Sponsors and Collaborators

• US Oncology Research
• Pfizer

Investigators

• Principal Investigator: Craig H. Reynolds, MD, US Oncology Research, LLC; Ocala Oncology Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Oncology Research
• ClinicalTrials.gov Identifier: NCT00864721
• Other Study ID Numbers: 06-135; GA6181UU
• First Posted: Mar 19, 2009
• Last Update Posted: Oct 16, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by US Oncology Research: Untreated NSCLC in patients > 70
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Sunitinib

Study Results

Participant Flow

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Period Title: Overall Study
STARTED	63
COMPLETED	29
NOT COMPLETED	34

Baseline Characteristics

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Overall Participants	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.7 (5.08)
Sex: Female, Male (Count of Participants)
Female	31 49.2%
Male	32 50.8%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	60 95.2%
Black	1 1.6%
Hispanic	1 1.6%
Other	1 1.6%
Region of Enrollment (participants) [Number]
United States	63 100%

Outcome Measures

1. Primary Outcome

Title	Disease Control Rate (DCR)
Description	Disease control rate = CR + PR + SD>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Time Frame	Every 6 weeks until progressive disease or death due to any cause, up to 36 month.

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Measure Participants	60
Number (95% Confidence Interval) [percentage of participants]	63.3 100.5%

2. Secondary Outcome

Title	Overall Response Rates (OR)
Description	Overall response rates = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	Every 6 weeks until progressive disease or death due to any causes, up to 36 months.

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Measure Participants	60
Number (95% Confidence Interval) [percentage of participants]	6.7 10.6%

3. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at the date of last contact. Progressive disease (PD) is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame	All patients were followed until progressive disease or death, up to 36 months.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Measure Participants	63
Median (Full Range) [months]	3.0

4. Secondary Outcome

Title	1-year Overall Survival (OS) Rate.
Description	OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.
Time Frame	All patients were followed until death or up to 36 months.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Measure Participants	63
Number (95% Confidence Interval) [percentage of participants alive at 1yr]	26 41.3%

5. Secondary Outcome

Title	Time to Progression (TTP)
Description	TTP is measured from the date of registration to the date of first documented disease progression or date of death due to progressive disease, whichever comes first. If a patient neither progresses nor dies due to progressive disease, this patient will be censored at the date of last contact. Progressive disease is defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame	All patients were followed until progressive disease or death, up to 36 months.

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Measure Participants	63
Median (Full Range) [months]	4.5

Adverse Events

Time Frame	During the whole treatment period, up to 30 days following last dose.
Adverse Event Reporting Description	For treated patients only, assessed at each treatment visit.
Arm/Group Title	Sunitinib Malate
Arm/Group Description	Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle. Sutent: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
All Cause Mortality
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	11/60 (18.3%)
Blood and lymphatic system disorders
ANEMIA HEMOLYTIC (NOS)	1/60 (1.7%)	1
HEMORRHAGE (NOS)	1/60 (1.7%)	1
THROMBOCYTOPENIA	3/60 (5%)	3
Cardiac disorders
CARDIAC FAILURE	1/60 (1.7%)	1
Gastrointestinal disorders
ABDOMINAL PAIN	1/60 (1.7%)	1
APPETITE DECREASED	2/60 (3.3%)	2
BLEEDING GASTROINTESTINAL	1/60 (1.7%)	1
COLITIS ULCERATIVE	1/60 (1.7%)	1
DEHYDRATION	2/60 (3.3%)	2
DIARRHEA	3/60 (5%)	4
JAUNDICE	1/60 (1.7%)	1
MUCOSITIS ORAL	1/60 (1.7%)	1
VOMITING	1/60 (1.7%)	1
General disorders
FATIGUE	2/60 (3.3%)	2
PAIN HEAD	1/60 (1.7%)	1
Infections and infestations
DIVERTICULITIS	1/60 (1.7%)	1
Other (Not Including Serious) Adverse Events
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	45/60 (75%)
Blood and lymphatic system disorders
ANEMIA	5/60 (8.3%)	7
NEUTROPENIA	9/60 (15%)	11
THROMBOCYTOPENIA	16/60 (26.7%)	24
Gastrointestinal disorders
ANOREXIA	13/60 (21.7%)	23
CONSTIPATION	8/60 (13.3%)	11
DEHYDRATION	4/60 (6.7%)	5
DIARRHEA	18/60 (30%)	26
DYSGUESIA	8/60 (13.3%)	8
GASTROESOPHAGEAL REFLUX	4/60 (6.7%)	4
NAUSEA	14/60 (23.3%)	19
PAIN MOUTH	3/60 (5%)	4
VOMITING	8/60 (13.3%)	12
General disorders
FATIGUE	26/60 (43.3%)	53
HEADACHE	3/60 (5%)	3
INSOMNIA	3/60 (5%)	4
WEAKNESS	6/60 (10%)	7
WEIGHT LOSS	6/60 (10%)	7
Infections and infestations
INFECTION FUNGAL	4/60 (6.7%)	5
MUCOSITIS	14/60 (23.3%)	20
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS	3/60 (5%)	5
Nervous system disorders
NEUROPATHY	4/60 (6.7%)	5
Renal and urinary disorders
PROTEINURIA	3/60 (5%)	3
Skin and subcutaneous tissue disorders
ERYTHEMA	3/60 (5%)	3
RASH	4/60 (6.7%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.