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Phase II Trial of Sunitinib (Sutent, SU11248) Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Extensive-Stage Small Cell Lung Cancer

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Trial Information

Phase II Trial of Sunitinib (Sutent, SU11248) Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

Despite a high initial response rate, all patients with extensive-stage SCLC 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

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.

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:

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patients will be evaluated for response according to the international RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

Outcome Time Frame:

All patients who have received at least one cycle of sunitinib will be considered evaluable for response to sunitinib

Safety Issue:


Principal Investigator

Gregory Kalemkerian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2007.034



Start Date:

September 2007

Completion Date:

June 2015

Related Keywords:

  • Extensive-Stage Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752