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Carboplatin, Gemcitabine, and Thalidomide in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00281827
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: thalidomide
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Gemcitabine hydrochloride Gemcitabine Thalidomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate at the end of 3 courses of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival at 1 and 2 years after treatment [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: May 2002
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the complete and partial response rates in patients with stage II or IIIA non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine hydrochloride, and thalidomide.

Secondary

  • Determine, preliminarily, the mechanism of action and activity of thalidomide against lung cancer.
  • Determine the 1-year and 2-year survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the operative mortality of patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive carboplatin IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with resectable tumors undergo surgical resection.

After completion of study treatment, patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:

    • Squamous cell carcinoma
    • Adenocarcinoma
    • Large cell undifferentiated carcinoma
  • Stage II or IIIA disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No tumor involving the superior sulcus (e.g., Pancoast tumor)

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2 mg/dL
  • Bilirubin < 2 mg/dL
  • AST < 3 times upper limit of normal
  • Not pregnant or nursing

    • No nursing during and for ≥ 4 weeks after completion of study treatment
  • Negative pregnancy test
  • Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
  • Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
  • No blood, sperm, or ova donation during study treatment
  • No post obstructive pneumonia
  • No other serious infection or medical illness that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years

PRIOR CONCURRENT THERAPY:

  • At least 5 years since prior resection of lung disease
  • No prior systemic chemotherapy or radiotherapy for NSCLC
  • No other concurrent chemotherapy or radiotherapy
  • No concurrent hormonal therapy or immunotherapy
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent participation in another clinical study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281827

Locations
United States, Minnesota
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Arkadiusz Dudek, MD Masonic Cancer Center, University of Minnesota
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Masonic Cancer Center at University of Minnesota ( Arkadiusz Dudek )
Study ID Numbers: CDR0000450907, UMN-2002LS013, LILLY-X-382, UMN-0202M17981
Study First Received: January 24, 2006
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00281827  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung
squamous cell lung cancer
large cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Thalidomide
Carboplatin
Carcinoma
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 15, 2009