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Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Diseases, Cancer

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Trial Information

Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.


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).


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin. The overall tumor response rate with this combination.

Outcome Time Frame:

Subjects will be followed in the clinic every four weeks to evaluate toxicity and tolerability.

Safety Issue:

Yes

Principal Investigator

Fa-Chyi Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

0100C

NCT ID:

NCT00249964

Start Date:

November 2003

Completion Date:

March 2011

Related Keywords:

  • Lung Diseases
  • Cancer
  • Extensive or recurrent small cell lung cancer Phase I
  • Paclitaxel, Carboplatin, Temozolomide
  • Lung Diseases

Name

Location

University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636