Clinical trial · Interventional
Combination Paclitaxel, Carboplatin and Temozolomide
Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.
NCT00249964CI-TRIAL-00020585completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Diseases | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination Treatment - Cohort 1 | Drug | — | UNRESOLVED |
| Combination Treatment - Cohort 2 | Drug | — | UNRESOLVED |
| Combination Treatment - Cohort 3 | Drug | — | UNRESOLVED |
| Combination Treatment - Cohort 4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Treatment
- description
- 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.
- interventionNames
- Drug: Combination Treatment - Cohort 1
- Drug: Combination Treatment - Cohort 2
- Drug: Combination Treatment - Cohort 3
- Drug: Combination Treatment - Cohort 4
Primary outcomes (1)
- measure
- Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin
- timeFrame
- 4 months
- description
- Temozolomide was administered at different dose levels (see Cohorts 1-4) until the maximum tolerated dose (MTD) was reached. MTD is the dose at which 0/6 or 1/6 patients in the cohort experience dose limiting toxicity (DLT) during the first 4 week cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will have occurred when the patient has 1 or more Grade 4 hematologic or nonhematologic toxicities. A DLT must occur in the first cycle of the combination and must be at least possibly attributed to the treatment regimen. Toxicities will be graded according to the NCI CTCAE Version 3.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.