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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
gemcitabine hydrochloride
thalidomide
conventional surgery
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Cancer Center
  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.

Outcomes

Primary Outcome Measures

Number of Patients Reporting Clinical Response
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.

Secondary Outcome Measures

Number of Patients Disease-free at 1 Year
Calculated from date of enrollment to date of recurrence or death, whichever came first
Number of Patients Disease-free at 2 Years
Calculated from date of enrollment to date of recurrence or death, whichever came first
Number of Patients Alive at 1 Year (Survival)
Participants who were alive at one year from date of enrollment .
Number of Patients Alive at 2 Years (Survival)
Participants who were alive at 2 years from date of enrollment.
Number of Patients Alive at 56 Months (End of Study)
Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).

Full Information

First Posted
January 24, 2006
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00281827
Brief Title
Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to drug unavailability
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
PARAPLATIN
Intervention Description
Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Other Intervention Name(s)
Gemzar
Intervention Description
Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
Intervention Type
Drug
Intervention Name(s)
thalidomide
Other Intervention Name(s)
Thalidomid
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Other Intervention Name(s)
Surgery, Resection
Intervention Description
Resection - between 2 and 6 weeks following last dose of chemotherapy.
Primary Outcome Measure Information:
Title
Number of Patients Reporting Clinical Response
Description
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.
Time Frame
At end of 3 -21 day cycles of treatment
Secondary Outcome Measure Information:
Title
Number of Patients Disease-free at 1 Year
Description
Calculated from date of enrollment to date of recurrence or death, whichever came first
Time Frame
1 year
Title
Number of Patients Disease-free at 2 Years
Description
Calculated from date of enrollment to date of recurrence or death, whichever came first
Time Frame
2 Years
Title
Number of Patients Alive at 1 Year (Survival)
Description
Participants who were alive at one year from date of enrollment .
Time Frame
12 Months
Title
Number of Patients Alive at 2 Years (Survival)
Description
Participants who were alive at 2 years from date of enrollment.
Time Frame
24 Months
Title
Number of Patients Alive at 56 Months (End of Study)
Description
Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).
Time Frame
Up to 56 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkadiusz Dudek, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States

12. IPD Sharing Statement

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

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