Combination Paclitaxel, Carboplatin and Temozolomide
The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 20, 2016 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- New Mexico Cancer Research Alliance
- Interventions being studied
- Drug: Combination Treatment - Cohort 1; Drug: Combination Treatment - Cohort 2; Drug: Combination Treatment - Cohort 3; Drug: Combination Treatment - Cohort 4
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Age greater than or equal to 18 years 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
1. No recovery from all active toxicities of prior therapies. 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of New Mexico Cancer CenterAlbuquerque, New Mexico
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 20, 2016. Always confirm current availability with the study team.