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A phase I/randomized phase II, non-comparative, multicenter, open label trial of CP-547,632 in combination with paclitaxel and carboplatin or paclitaxel and carboplatin alone as first-line treatment for advanced non-small cell lung cancer (NSCLC)
- Source :
- Cancer Chemotherapy and Pharmacology. 60:81-89
- Publication Year :
- 2006
- Publisher :
- Springer Science and Business Media LLC, 2006.
-
Abstract
- To evaluate the toxicity profile and pharmacological properties of oral CP-547,632 alone and in combination with paclitaxel and carboplatin administered every 3 weeks, and to assess efficacy as measured by the objective response and progressive disease rates of oral CP-547,632 administered in combination with paclitaxel and carboplatin. Patients with stage IIIB/IV or recurrent non-small cell lung cancer receiving first-line chemotherapy were treated with oral daily CP-547,632 in combination with paclitaxel 225 mg/m2 and carboplatin AUC = 6 every 3 weeks. Pharmacokinetics parameters for CP-547,632 and paclitaxel were determined independently and during co-administration. Seventy patients were enrolled and 68 patients were treated, 37 in phase 1 and 31 in phase 2 (14 with the combination and 17 with chemotherapy alone). Dose-limiting toxicity of CP-547,632 250 mg by mouth daily in combination with paclitaxel and carboplatin was grade 3 rash and grade 3 diarrhea despite medical intervention. CP-547,632 did not significantly affect the pharmacologic profiles of paclitaxel and carboplatin. No subject had CR. In phase I, seven subjects (22.6%) had a confirmed partial response. In phase II, four subjects (28.6%) receiving CP-547,632 plus chemotherapy had a confirmed partial response. In the phase II chemotherapy alone group, four subjects (25%) had a confirmed partial response. The combination of CP-547,632 and paclitaxel and carboplatin was well-tolerated at doses up to 200 mg by mouth daily. Dose-limiting toxicity of CP-547,632 at 250 mg consisted of diarrhea and rash. CP-547,632 did not increase the objective response rate to chemotherapy alone in patients with advanced non-small cell lung cancer.
- Subjects :
- Male
Oncology
Cancer Research
Lung Neoplasms
Gastrointestinal Diseases
medicine.medical_treatment
Administration, Oral
non-small cell lung cancer (NSCLC)
Toxicology
Carboplatin
chemistry.chemical_compound
Carcinoma, Non-Small-Cell Lung
Antineoplastic Combined Chemotherapy Protocols
Urea
Pharmacology (medical)
Middle Aged
Prognosis
Rash
Treatment Outcome
Paclitaxel
Area Under Curve
Female
medicine.symptom
Half-Life
Adult
Diarrhea
medicine.medical_specialty
Drug Administration Schedule
Pharmacokinetics
Internal medicine
medicine
Humans
Lung cancer
Aged
Neoplasm Staging
Pharmacology
Chemotherapy
Dose-Response Relationship, Drug
business.industry
Exanthema
medicine.disease
Hematologic Diseases
Surgery
Thiazoles
chemistry
business
Progressive disease
Subjects
Details
- ISSN :
- 14320843 and 03445704
- Volume :
- 60
- Database :
- OpenAIRE
- Journal :
- Cancer Chemotherapy and Pharmacology
- Accession number :
- edsair.doi.dedup.....d4983b66e10f2d7d4de02d0cb1aba286