Clinical trial NCT00249964: Combination Paclitaxel, Carboplatin and Temozolomide
Official title: Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Diseases
Cancer
Keywords: Extensive or recurrent small cell lung cancer Phase I
Paclitaxel, Carboplatin, Temozolomide
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin
timeFrame: 4 months
Secondary outcomes:
measure: Tumor response rate
timeFrame: 7 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Fa-Chyi Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: