Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00041314
First received: July 8, 2002
Last updated: June 6, 2009
Last verified: August 2002
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: exisulind Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | August 2002 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
- Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined modality therapy OR
- Stage IV
Prior brain metastases are allowed provided the following are true:
- Patient completed radiotherapy and/or surgery at least 3 weeks prior to study
- Objective evidence of resolution or significant improvement of brain lesions exists on follow-up CT scan or MRI
- Patient is neurologically improved or stable
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- WBC at least 3,000/mm^3
- Hemoglobin at least 9 g/L
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.25 mg/dL
- SGOT no greater than 1.5 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No prior uncontrolled cardiovascular disease
- No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No serious active infection
- No dementia or active psychoses
- No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 1 month since prior investigational agents
- More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)
- No concurrent sulindac or COX-2 inhibitors
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041314
Show 79 Study Locations
Show 79 Study LocationsSponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
| Study Chair: | Gregory A. Masters, MD | NorthShore University HealthSystem Research Institute |
More Information
Additional Information:
Publications:
Masters GA, Xu R, Langer C, et al.: A phase II trial of carboplatin and gemcitabine with exisulind (IND # 65,056) in patients with advanced non-small cell lung cancer: Eastern Cooperative Oncology Group trial 1501. [Abstract] J Clin Oncol 22 (Suppl 14): A-7037, 626s, 2004.
| ClinicalTrials.gov Identifier: | NCT00041314 History of Changes |
| Other Study ID Numbers: | CDR0000069467, E-E1501 |
| Study First Received: | July 8, 2002 |
| Last Updated: | June 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Sulindac sulfone Carboplatin Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Anticarcinogenic Agents Protective Agents Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal |
ClinicalTrials.gov processed this record on May 19, 2013