Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

This study has been terminated.
(Due to drug unavailability)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00281827
First received: January 24, 2006
Last updated: November 6, 2012
Last verified: November 2012

January 24, 2006
November 6, 2012
May 2002
March 2008   (final data collection date for primary outcome measure)
Number of Patients Reporting Clinical Response [ Time Frame: At end of 3 -21 day cycles of treatment ] [ Designated as safety issue: No ]
Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.
Not Provided
Complete list of historical versions of study NCT00281827 on ClinicalTrials.gov Archive Site
  • Number of Patients Disease-free at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Calculated from date of enrollment to date of recurrence or death, whichever came first
  • Number of Patients Disease-free at 2 Years [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Calculated from date of enrollment to date of recurrence or death, whichever came first
  • Number of Patients Alive at 1 Year (Survival) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Participants who were alive at one year from date of enrollment .
  • Number of Patients Alive at 2 Years (Survival) [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    Participants who were alive at 2 years from date of enrollment.
  • Number of Patients Alive at 56 Months (End of Study) [ Time Frame: Up to 56 months ] [ Designated as safety issue: Yes ]
    Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).
Not Provided
Not Provided
Not Provided
 
Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer
Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer

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.

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 intravenously (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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
    Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
    Other Name: PARAPLATIN
  • Drug: gemcitabine hydrochloride
    Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
    Other Name: Gemzar
  • Drug: thalidomide
    Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.
    Other Name: Thalidomid
  • Procedure: conventional surgery
    Resection - between 2 and 6 weeks following last dose of chemotherapy.
    Other Names:
    • Surgery
    • Resection
Experimental: Treatment Arm
Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.
Interventions:
  • Drug: carboplatin
  • Drug: gemcitabine hydrochloride
  • Drug: thalidomide
  • Procedure: conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
July 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Computerized Axial Tomography (CT) scan
  • No tumor involving the superior sulcus (e.g., Pancoast tumor)
  • 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
  • Aspartate aminotransferase (AST) < 3 times upper limit of normal

Exclusion Criteria:

  • Pregnant or nursing

    • No nursing during and for ≥ 4 weeks after completion of study treatment
  • Positive 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
  • Blood, sperm, or ova donation during study treatment
  • Post obstructive pneumonia
  • Other serious infection or medical illness that would preclude study participation
  • 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
  • Less than 5 years since prior resection of lung disease
  • Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
  • Other concurrent chemotherapy or radiotherapy
  • Concurrent hormonal therapy or immunotherapy
  • Other concurrent anticancer therapy
  • Other concurrent investigational agents
  • Concurrent participation in another clinical study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00281827
2002LS013, LILLY-X-382, 0202M17981
Yes
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Study Chair: Arkadiusz Dudek, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP