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Sponsored by: |
Hope Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003562 |
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 combining docetaxel and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Non-Small Cell Cancer of the Lung Utilizing Low-Dose Weekly Therapy of Taxotere and Carboplatin |
Estimated Enrollment: | 38 |
Study Start Date: | July 1998 |
OBJECTIVES: I. Determine the effectiveness of low dose docetaxel and carboplatin by response rate, response duration, and time to progression in patients with stage IIIB or IV non-small cell lung cancer. II. Determine the side effects and toxicity profile of docetaxel when given in combination with carboplatin in these patients.
OUTLINE: This is open label study. Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 30 minutes once a week for 4 weeks. Patients receive at least 2 courses (8 weeks) of treatment. Courses are further repeated in the absence of unacceptable toxicity and disease progression.
PROJECTED ACCRUAL: There will be 20-38 patients accrued into this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB with metastatic pleural effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable or evaluable indicator lesion(s) must be completely outside the radiation portal or there must be proof of disease progression No current CNS metastases at study entry No meningeal carcinomatosis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal: Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect assessment of this study Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease) is allowed during study, but chemotherapy is stopped during and for 2 weeks following radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective criteria for disease progression Surgery: Not specified Other: No other concurrent experimental drug
United States, Kansas | |
Bethany Medical Center | |
Kansas City, Kansas, United States, 66102 | |
Heartland Cancer Research Network | |
Kansas City, Kansas, United States, 66106 |
Study Chair: | Raj Sadasivan, MD, PhD | Hope Cancer Institute |
Study ID Numbers: | CDR0000066626, HCRN-007, NCI-V98-1469 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003562 History of Changes |
Health Authority: | United States: Federal Government |
squamous cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
Docetaxel Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Carboplatin Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Carboplatin Pharmacologic Actions Carcinoma Docetaxel |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |