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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00074204 |
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Date of registration:
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10/12/2003 |
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Primary sponsor: |
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Public title:
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Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Scientific title:
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A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00074204 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Nathan Levitan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB with pleural effusion OR stage IV disease
- Recurrent disease after primary treatment with radiotherapy or surgery allowed
- Measurable disease or nonmeasurable disease
- Measurable disease, defined as at least 1 unidimensionally measurable lesion at
least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Nonmeasurable disease, defined as all other lesions, including small lesions
(longest diameter less than 20 mm by conventional techniques OR less than 10 mm
by spiral CT scan) or any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Cystic lesions
- Abdominal masses not confirmed and followed by imaging techniques
- No symptomatic CNS metastases
- Treated, stable CNS metastases allowed provided patient is not receiving
radiotherapy or corticosteroids
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN
for patients with documented benign disease)
- Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign
disease)
Renal
- Creatinine no greater than 1.5 mg/dL
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study
participation
- No active and ongoing infection
- No concurrent serious systemic disorder that would preclude study participation
- No other primary malignancy within the past 5 years except carcinoma in situ of the
cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in
remission
- Other prior cancers unlikely to affect survival for the next 3 years (e.g.,
low-grade early stage prostate cancer) are allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- No concurrent antitumor hormonal therapy (excluding contraceptives and replacement
steroids)
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated
area is not the only site of measurable disease
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 3 weeks since prior therapy for cancer
- More than 4 weeks since prior investigational agents
- No other concurrent experimental medications
- No other concurrent therapy for cancer
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Drug: carboplatin
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Drug: docetaxel
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Drug: gemcitabine hydrochloride
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Primary Outcome(s)
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Survival
[Time Frame: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter]
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Secondary Outcome(s)
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Quality of life as measured by the lung cancer symptom scale
[Time Frame: At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.]
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Response rate (partial and complete response)
[Time Frame: Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter]
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Time to progression
[Time Frame: treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.]
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Toxicity as measured by NCI CTC
[Time Frame: at baseline and at the end of each course not at day 8]
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Secondary ID(s)
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CASE-CWRU-LILY-1503
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LILLY-B9E-US-S245
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LILY1503
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P30CA043703
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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