Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2003-11-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination Treatment
Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days).
Cycle length is 21 days.
Combination Treatment - Cohort 1
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 75 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 2
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 100 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 3
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 125 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 4
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 150 mg/m2 per day from day 2 to day 6.
Interventions
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Combination Treatment - Cohort 1
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 75 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 2
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 100 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 3
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 125 mg/m2 per day from day 2 to day 6.
Combination Treatment - Cohort 4
Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1.
Temozolomide at 150 mg/m2 per day from day 2 to day 6.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B)
3. Laboratory values (performed within 14 days prior to study drug administration, inclusive).
1. Absolute neutrophil count (ANC) \>1500/mm3
2. Platelet count \>100,000/mm3
3. Hemoglobin \>10 g/dl or 100 g/l
4. BUN and serum creatinine \<1.5 times upper limit of laboratory normal
5. Total and direct bilirubin \<1.5 times upper limit of laboratory normal
6. SGOT and SGPT \<3 times upper limit of laboratory normal
7. Alkaline Phosphatase \<3 times upper limit of laboratory normal
4. A life expectancy of greater than 12 weeks
5. Subjects must give written informed consent.
6. Biopsy proven small cell lung cancer.
7. CT of chest, abdomen, pelvis and MRI of head
8. Patients with brain metastases should be asymptomatic to enter the study
Exclusion Criteria
2. Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
3. Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
4. Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
5. Known HIV positivity or AIDS-related illness.
6. Pregnant or nursing women.
7. Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
8. Men who are not advised to use an effective method of contraception.
9. Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination.
10. Known hypersensitivity reaction to taxoid or platinum compound.
18 Years
ALL
No
Sponsors
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New Mexico Cancer Research Alliance
OTHER
Responsible Party
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Principal Investigators
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Fa-Chyi Lee, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Locations
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University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Countries
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Other Identifiers
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0100C
Identifier Type: -
Identifier Source: org_study_id
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