Status:
COMPLETED
Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anemia
Drug/Agent Toxicity by Tissue/Organ
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, ma...
Detailed Description
OBJECTIVES: Primary * Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without di...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed\* non-small cell lung cancer of 1 of the following subtypes:
- Squamous carcinoma
- Basaloid carcinoma
- Adenocarcinoma
- Bronchoalveolar carcinoma
- Adenosquamous carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Giant cell carcinoma
- Sarcomatoid carcinoma
- Non-small cell carcinoma not otherwise specified NOTE: \*Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection
- Stage IIIB disease due to malignant pleural effusion OR stage IV disease
- Measurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- The following are considered nonmeasurable disease:
- Bone lesions
- Brain metastases or leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
- Brain metastases are allowed provided patient is neurologically stable and off steroids
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Renal
- Creatinine ≤ ULN
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No grade 2 or greater neuropathy
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No other concurrent growth factors
- Chemotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
- Endocrine therapy
- See Disease Characteristics
- No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
- Radiotherapy
- See Disease Characteristics
- Prior radiotherapy allowed for brain metastases only
- No concurrent palliative radiotherapy
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00077311
Start Date
August 1 2004
End Date
April 1 2009
Last Update
June 30 2016
Active Locations (64)
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1
El Camino Hospital
Mountain View, California, United States, 94040
2
Beebe Medical Center
Lewes, Delaware, United States, 19958
3
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
4
St. Francis Hospital
Wilmington, Delaware, United States, 19805