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Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients.

ABSTRACT: Cyclooxygenase-2 overexpression is associated with poor outcome and resistance to platinum-based chemotherapy in ovarian cancer. We evaluated the antitumor activity and safety of the combination carboplatin plus the COX-2 inhibitor celecoxib in recurrent heavily-treated OC patients.Patients were administered oral celecoxib (400 mg/day) in combination with intravenous carboplatin (AUC5, q28). A Simon's two-stage design was employed.45 patients were enrolled: 23 (51.1%) presented platinum-resistance, and 27 (60%) had received at least 3 prior regimens for recurrence. The response rate was 28.9% with 3 complete and 10 partial responses (median duration of response = 6 months). Only one (0.4%) G4 non-febrile neutropenia was observed; G3 neutropenia, anemia, or thrombocytopenia, were observed in 2.5%, 1.7%, and 1.7% of the cycles, respectively. G3-4 vomiting was reported in only 1.7%, and 0.4% of the cycles were associated with G3 dyspepsia or diarrhea or constipation. Only one patient experienced G3 hypertension associated to G2 hypersensitivity reaction. No differences in baseline versus post-treatment Quality of Life scores were observed. Median progression free survival and overall survival were 5 and 13 months, respectively.Celecoxib combined with carboplatin showed promising activity and it is well tolerated in heavily-treated recurrent ovarian cancer patients.NCT01124435 (ClinicalTrials.gov Identifier) and 935/03 (study ID numbers).

SUBMITTER: Legge F

PROVIDER: S-EPMC3123659 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients.

Legge Francesco F Paglia Amelia A D'Asta Marco M Fuoco Gilda G Scambia Giovanni G Ferrandina Gabriella G

BMC cancer 20110531

<h4>Background</h4>Cyclooxygenase-2 overexpression is associated with poor outcome and resistance to platinum-based chemotherapy in ovarian cancer. We evaluated the antitumor activity and safety of the combination carboplatin plus the COX-2 inhibitor celecoxib in recurrent heavily-treated OC patients.<h4>Methods</h4>Patients were administered oral celecoxib (400 mg/day) in combination with intravenous carboplatin (AUC5, q28). A Simon's two-stage design was employed.<h4>Results</h4>45 patients we ...[more]

PMID: 21627839

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Project description:PURPOSE:Afatinib, an irreversible ErbB family blocker, has demonstrated preclinical antitumor activity with chemotherapy. METHODS:As part of a phase I trial in patients with advanced solid tumors (NCT00809133; 3?+?3 dose-escalation design), we determined the maximum tolerated dose (MTD) of afatinib with carboplatin (A/C) or with carboplatin plus paclitaxel (A/C/P). Starting doses: afatinib 20 mg/day, carboplatin AUC6 (A/C) with paclitaxel 175 mg/m2 (A/C/P) (chemotherapy: Day 1 of 21-day cycles). The primary objective was to determine the MTDs; safety, pharmacokinetics and antitumor activity were also evaluated. RESULTS:Thirty-eight patients received A/C (n?=?12) or A/C/P (n?=?26). No dose-limiting toxicities (DLTs) were reported with A(20 mg)/C(AUC6). One patient experienced DLT in the A(40 mg)/C(AUC6) cohort (grade 3 acneiform rash); A(40 mg)/C(AUC6) was determined as the recommended phase II dose (RP2D) for A/C. Two patients each had DLTs with A(20 mg/day)/C(AUC6)/P(175 mg/m2): fatigue, infection, diarrhea, small intestine hemorrhage, dehydration, renal impairment, neutropenic sepsis (n?=?1), mucositis (n?=?1); A(40 mg)/C(AUC5)/P(175 mg/m2): febrile neutropenia (n?=?1), mucositis, fatigue (n?=?1); and A(30 mg)/C(AUC5)/P(175 mg/m2): stomatitis (n?=?1), mucositis (n?=?1). No DLT was observed with A(20 mg)/C(AUC5)/P(175 mg/m2), determined as the RP2D for A/C/P. The most frequent drug-related adverse events were (A/C; A/C/P): rash (75%; 73%), fatigue (67%; 69%), and diarrhea (58%; 88%). Drug plasma concentrations were similar between cycles, suggesting no drug-drug interactions. Objective response rates in these heavily pretreated patients were A/C, 3/12 (25%); A/C/P, 5/26 (19%). CONCLUSIONS:Afatinib 40 mg/day (approved monotherapy dose) with carboplatin AUC6, and afatinib 20 mg/day with carboplatin AUC5 and paclitaxel 175 mg/m2 demonstrated manageable safety and antitumor activity. Afatinib?>?20 mg/day in the triple combination was not well tolerated.

Dataset Information

Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients.

Publications

Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients.

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