Status:
TERMINATED
Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Tha...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00281827
Start Date
May 1 2002
End Date
July 1 2008
Last Update
December 28 2017
Active Locations (3)
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1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
2
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
3
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002