CompletedNCT00616109Updated Apr 21, 2014Results posted

Sunitinib Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With ES-SCLC

A Phase 2 interventional study of sunitinib in Extensive-Stage Small Cell Lung Cancer, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-21.

Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 16
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The goal of this study is to determine the progression-free survival rate in patients with extensive-stage small cell lung cancer who had achieved complete response, partial response, or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or carboplatin in combination with etoposide or irinotecan. In addition, the safety and effectiveness of sunitinib will also be evaluated.

Read the detailed description

Despite a high initial response rate, all patients with extensive-stage small cell lung cancer treated with standard chemotherapy will develop disease progression, usually within one year of initial treatment. Therefore, prolonging progression-free survival in this disease is meaningful for clinical trials exploring agents such as sunitinib. Sunitinib is a drug that inhibits the biological pathway responsible for the growth and spread of cancer cells. For this reason, we believe that sunitinib maintenance therapy will delay or prevent recurrence and prolong survival.

Conditions studied

Extensive-Stage Small Cell Lung Cancer

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 16 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Histologically or cytologically confirmed extensive-stage SCLC. Extensive-stage is defined as disease that extends beyond one hemithorax and regional lymph nodes (ipsilateral or contralateral hilar, mediastinal, or supraclavicular lymph nodes), or with cytologically positive pleural effusion.
Patients who have completed platinum-based chemotherapy and demonstrated a complete response, partial response, or stable disease can be registered on the trial. A maximum of 4 cycles of induction chemotherapy is allowed. Patients must begin therapy within 28-42 days after day 1 of the 4th cycle of induction therapy and within 28 days of scans demonstrating stable disease or better. Prior palliative radiation therapy will be allowed as long as radiation was completed at least 1 week before starting protocol therapy.
Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade 1.
Age * 18 years with Southwest Oncology Group (SWOG) performance status of 0,1 or 2 (Appendix 2).
Adequate organ function as evidenced by the laboratory values listed in the protocol

Exclusion criteria

Exclusion Criteria:

Symptomatic or untreated brain or leptomeningeal metastases. Treated patients should be neurologically stable for at least 2 weeks after completion of appropriate therapy without the use of steroids. Patients currently on steroids are ineligible.
More than 4 cycles of induction chemotherapy. Patients will be eligible for if they have completed at least 2 cycles of platinum-based induction chemotherapy and they have exhibited a complete or partial response to therapy. Patients who have received less than 4 cycles of induction chemotherapy and have less than a partial response will not be eligible.
NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.
History of gross hemoptysis due to lung cancer.
Previous or concurrent malignancies, with the exception of adequately treated squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any other malignancy treated and in clinical remission for more than 3 years.
Major surgery or within 4 weeks of starting study treatment.
Any history 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 (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
Ongoing cardiac dysrhythmias
Hypertension that cannot be controlled by medications
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
Therapeutic anticoagulation with warfarin or heparin.
Serious concomitant medical illness, including, but not limited to, uncontrolled angina, myocardial infarction and/or stroke within 3 months, or HIV infection.
Acute or chronic liver disease
History of dementia, active psychiatric disorder or any other condition, considered by the treating physician to impair the patient's ability to take oral pills on a daily basis or comply with the protocol requirements.
Pregnant or lactating females.
Use of agents with proarrhythmic potential is not permitted during the study.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
Maintenance Sunitinib
Main interventional arm of study. Subjects who received maintenance sunitinib experimentally on this study were from a population of (consenting) patients with histologically or cytologically documented Extensive-State Small Cell Lung Cancer (ES-SCLC) who did not progress (were classified as Complete Response or "CR", Partial Response or "PR", or Stable Disease or "SD") after an induction chemotherapy (Cisplatin and etoposide)
Drug: sunitinib

Interventions

Drugsunitinib
Sunitinib will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
Also known as: Sutent

What researchers measure

Primary outcomes

Progression Free Survival Rate
The proportion of patients who are progression-free at 4 months after starting sunitinib.
Time frame: 4 Months Post Treatment

Secondary outcomes

Median Overall Survival
Survival will be defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. Survival for induction therapy will be calculated from day 1 of first cycle of chemotherapy. Survival for post-induction therapy will be calculated from the date the patient starts sunitinib.
Time frame: up to 4 months post treatment
Percent of Patients With an Objective Response
Scans were performed every 2 cycles to evaluate for response/progression. Response was assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Patients would be considered to have an objective response if they experience CR (Complete Response - Disappearance of all clinical and radiological evidence of target lesions and/or non-target lesions) or PR (Partial Response - A 30% or greater decrease in the sum of LD of all lesions in reference to the baseline sum LD).
Time frame: 12 weeks (2 cycles)
Number of Patients That Discontinue Drug Due to Toxicity
Tolerability of Sunitinib will be evaluated by looking at the number of participants who discontinue drug due to toxicity. Toxicity was graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v.3.0. In the event of any CTC, version 3.0 drug-related grade 3 or 4 non-hematologic or grade 4 hematologic adverse event(s), drug should be held until the toxicity resolves to \< grade 1 and then the drug should be restarted at a one dose-level reduction. Recovery to acceptable levels of toxicity must occur within 4 weeks to allow continuation in the study. No more than 2 dose reductions are permitted for any patient. If further dose reduction is required, the patient must be removed from the study.
Time frame: 20 weeks

Results

Posted Apr 21, 2014

Limitations and caveats

The trial was to be terminated at stage 1 if less than, or equal to, 8 patients were progression free at 4 months. The PFS rate did not reach the threshold required for study continuation and, therefore, the study was discontinued early.

Participant flow

16 subjects recruited from 7/19/2007 to 2/1/2010 at University of Michigan, Ann Arbor(lead site), and sub-sites: The University of Detroit's Karmanos Cancer Institute, WSU, Detroit; Weill Cornell Medical College, NY; and Roswell Park Cancer Institute, NJ

Participant flow — Overall Study
Milestone	Sunitinib Maintenance Therapy
Started	16
Completed	16
Not completed	0

Outcome measures

PrimaryProgression Free Survival Rate

The proportion of patients who are progression-free at 4 months after starting sunitinib.

Time frame:: 4 Months Post Treatment
Reported as:: Number · percentage of patients with PFS

Progression Free Survival Rate
percentage of patients with PFS	Sunitinib Maintenance Therapy
Progression Free Survival Rate	13 (2 to 33)

SecondaryMedian Overall Survival

Survival will be defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. Survival for induction therapy will be calculated from day 1 of first cycle of chemotherapy. Survival for post-induction therapy will be calculated from the date the patient starts sunitinib.

Time frame:: up to 4 months post treatment
Reported as:: Median · months

Median Overall Survival
months	Sunitinib Maintenance Therapy
Median Overall Survival	8.2 (6.2 to 14.7)

SecondaryPercent of Patients With an Objective Response

Scans were performed every 2 cycles to evaluate for response/progression. Response was assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Patients would be considered to have an objective response if they experience CR (Complete Response - Disappearance of all clinical and radiological evidence of target lesions and/or non-target lesions) or PR (Partial Response - A 30% or greater decrease in the sum of LD of all lesions in reference to the baseline sum LD).

Time frame:: 12 weeks (2 cycles)
Reported as:: Number · percentage of participants

Percent of Patients With an Objective Response
percentage of participants	Sunitinib Maintenance Therapy
Percent of Patients With an Objective Response	0

SecondaryNumber of Patients That Discontinue Drug Due to Toxicity

Tolerability of Sunitinib will be evaluated by looking at the number of participants who discontinue drug due to toxicity. Toxicity was graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v.3.0. In the event of any CTC, version 3.0 drug-related grade 3 or 4 non-hematologic or grade 4 hematologic adverse event(s), drug should be held until the toxicity resolves to \< grade 1 and then the drug should be restarted at a one dose-level reduction. Recovery to acceptable levels of toxicity must occur within 4 weeks to allow continuation in the study. No more than 2 dose reductions are permitted for any patient. If further dose reduction is required, the patient must be removed from the study.

Time frame:: 20 weeks
Reported as:: Number · participants

Number of Patients That Discontinue Drug Due to Toxicity
participants	Sunitinib Maintenance Therapy
Number of Patients That Discontinue Drug Due to Toxicity	5

Adverse events

Collected over Participants were evaluated for toxicity if they received sunitinib maintenance therapy (at least one dose) from onset of this therapy until the participant ended participation.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sunitinib Maintenance Therapy	—	4/16 (25%)	16/16 (100%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Sunitinib Maintenance Therapy
ThrombocytopeniaBlood and lymphatic system disorders	1/16
Abdominal painGastrointestinal disorders	1/16
Alanine aminotransferase increasedMetabolism and nutrition disorders	1/16
Alkaline phosphatase increasedMetabolism and nutrition disorders	1/16
Aspartate aminotransferase increasedMetabolism and nutrition disorders	1/16
Bronchial obstructionRespiratory, thoracic and mediastinal disorders	1/16
Cardiac ischemia/infarctionCardiac disorders	1/16
Cardiopulmonary arrestCardiac disorders	1/16
Chest painCardiac disorders	1/16
ConfusionPsychiatric disorders	1/16

Most frequent other events

Showing 10 of 42

Most frequent other events
Event	Sunitinib Maintenance Therapy
FatigueGeneral disorders	10/16
NauseaGastrointestinal disorders	10/16
PlateletsBlood and lymphatic system disorders	7/16
VomitingGastrointestinal disorders	7/16
HeadacheNervous system disorders	6/16
AnorexiaMetabolism and nutrition disorders	5/16
Back painMusculoskeletal and connective tissue disorders	5/16
ConstipationGastrointestinal disorders	5/16
CoughRespiratory, thoracic and mediastinal disorders	5/16
DiarrheaGastrointestinal disorders	5/16

Baseline characteristics

Lung cancer patients who are greater than or equal to 18 years old, who have had a response or maintained stable disease after undergoing no more that 4 cycles with platinum with etoposide chemotherapy

Age, Customized
Age, Customized(years)	Sunitinib Maintenance Therapy
Mean	66 (34 to 80)

Sex: Female, Male
Sex: Female, Male(Participants)	Sunitinib Maintenance Therapy
Female	8
Male	8

Region of Enrollment
Region of Enrollment(participants)	Sunitinib Maintenance Therapy
United States	16

Response to induction chemotherapy
Response to induction chemotherapy(participants)	Sunitinib Maintenance Therapy
CR (complete response)	3
PR (partial response)	11
SD (stable disease)	2

Performance status
Performance status(participants)	Sunitinib Maintenance Therapy
0	5
1	10
2	1

Study locations

1 site

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109, United States

References and documents

Publications

Schneider BJ, Gadgeel SM, Ramnath N, Wozniak AJ, Dy GK, Daignault S, Kalemkerian GP. Phase II trial of sunitinib maintenance therapy after platinum-based chemotherapy in patients with extensive-stage small cell lung cancer. J Thorac Oncol. 2011 Jun;6(6):1117-20. doi: 10.1097/JTO.0b013e31821529c3. PubMed 21512407 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00616109
Lead sponsor: University of Michigan Rogel Cancer Center
Responsible party: Gregory Kalemkerian. M.D. (Professor of Internal Medicine, University of Michigan Rogel Cancer Center) — Principal investigator
First posted: Feb 15, 2008
Start date: Sep 2007
Primary completion: Dec 2009
Completion: Jan 2011
Results posted: Apr 21, 2014
Last update: Apr 21, 2014

Study contacts

Gregory Kalemkerian, MD

principal investigator · University of Michigan Rogel Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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