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Sunitinib Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by University of Michigan Cancer Center, February 2009
First Received: February 4, 2008   Last Updated: February 13, 2009   History of Changes
Sponsored by: University of Michigan Cancer Center
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00616109
  Purpose

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.


Condition Intervention Phase
Extensive-Stage Small Cell Lung Cancer
Drug: sunitinib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Sunitinib malate Sunitinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Phase II Trial of Sunitinib (Sutent, SU11248) Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Patients will be evaluated for response according to the international RECIST (Response Evaluation Criteria in Solid Tumors) criteria. [ Time Frame: All patients who have received at least one cycle of sunitinib will be considered evaluable for response to sunitinib ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival will be reported for patients. [ Time Frame: the duration of the study ] [ Designated as safety issue: No ]
  • The objective response rate associated with sunitinib in patients with partial response or stable disease after induction chemotherapy will be assessed. [ Time Frame: two cycles of sunitinib ] [ Designated as safety issue: No ]
  • Tolerability will be described. [ Time Frame: This description will include proportions and 95% confidence intervals for completion of 1 cycle and 2 cycles of sunitinib, dose modifications due to toxicity, and the types and grades of toxicities reported. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: September 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: sunitinib
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.

Detailed Description:

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 survival.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616109

Contacts
Contact: Gregory Kalemkerian, MD 734-615-4762 kalemker@umich.edu

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Gregory Kalemkerian, MD     734-615-4762     kalemker@umich.edu    
Principal Investigator: Gregory Kalemkerian, MD            
Sub-Investigator: David Reisman, MD            
Sub-Investigator: Nithya Ramnath, MD            
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Gregory Kalemkerian, MD University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: University of Michigan Comprehensive Cancer Center ( Gregory Kalemkerian, MD )
Study ID Numbers: UMCC 2007.034, HUM12046
Study First Received: February 4, 2008
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00616109     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Angiogenesis Inhibitors
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Sunitinib
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sunitinib
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009