A phase II study of gemcitabine plus carboplatin in platinum-sensitive, recurrent ovarian carcinoma

Köse, Mehmet; Šufliarský, Jozef; Beslija, S.; Saip, Pınar; Tulunay, Gökhan; Krejcy, Kurt; Minařík, Tomáš; Fitzthum, E.; Hayden, Anna Marie; Melemed, Allen S.

doi:10.1016/j.ygyno.2004.10.011

Cited by 30 publications

(19 citation statements)

References 19 publications

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“…Besides, addition of carboplatin to other drugs has been associated with an increased potential for myelotoxicity, similar to that found in this phase I study [35,36]. Therefore, the necessity to reduce the dose of carboplatin when combined with trabectedin is not unexpected.…”

Section: Discussionsupporting

confidence: 77%

Phase I clinical and pharmacokinetic study of trabectedin and carboplatin in patients with advanced solid tumors

et al. 2010

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Section: Discussionsupporting

confidence: 77%

Phase I clinical and pharmacokinetic study of trabectedin and carboplatin in patients with advanced solid tumors

et al. 2010

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“…CR was seen in patients at dose level 1 and dose level 3, PR was seen on all other dose levels. The median progression-free survival of 8.3 months is consistent with the results seen in this patient group in other phase I/II trials (Kose et al, 2005).…”

Section: Discussionsupporting

confidence: 90%

Combination chemotherapy with carboplatin, capecitabine and epirubicin (ECarboX) as second- or third-line treatment in patients with relapsed ovarian cancer: a phase I/II trial

et al. 2005

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Platinum-based combination chemotherapy has been proven to be superior to single-agent platinum in the treatment of relapsed ovarian cancer after a treatment-free interval of more than 6 months. A response rate of 41% was previously reported by our group using a combination of epirubicin, cisplatin and 5-FU in patients who relapsed within 12 months, we therefore assessed a similar, but more convenient combination of epirubicin, carboplatin and capecitabine in this phase-I/II trial. In total, 18 patients with recurrent epithelial ovarian carcinoma, who had not received more than two lines of chemotherapy and the treatment-free interval exceeded 6 months were treated with carboplatin AUC5, epirubicin 50 mg m À2 and capecitabine at several dose levels on continuous 21 day cycles and 14 of 21 day cycles. Patients were assessed for toxicity and by CT and CA-125 for response. The overall response rate was 61.1%, with three complete and eight partial responses. Grade 3/4 haematological toxicity was seen in 10 out of 18 patients and caused dose reductions and treatment delays. The combination of epirubicin, carboplatin and capecitabine showed good activity but caused excessive toxicity. A phase-II trial using carboplatin and capecitabine is underway.

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“…Gemcitabine has an advantageous toxicity profile, justifying its application as second-line chemotherapy. In patients with platinum-sensitive relapse, a 62.5% objective response rate was achieved in a population of 40 patients (15% CR and 47.5% PR), whereas the effect was also reported in the group of patients whose primary treatment was completed 6-12 months ago [31]. Median time-to-treatment failure was 9.3 months.…”

Section: Discussionmentioning

confidence: 90%

“…Gemcitabine and cisplatin combination treatments of relapsing ovarian cancers have resulted in objective responses of 40-50%, PFS of about 6 months, and overall survival of about 12 months, depending on the patients' previous treatment [26][27][28][29]. Evidence for the gemcitabine and carboplatin combination is less extensive, though in several phase II studies patients with relapsing tumors have achieved a response in 40%-70% of cases, time to progression of 7-10 months, and overall survival of up to 2 years [30][31][32][33]. Since 2000, the combination of gemcitabine and carboplatin is widely used within routine clinical practice in the Slovak and Czech Republics, and is currently registered in most European countries for the treatment of relapsing ovarian cancer based on the results of a phase III registrational trial [34].…”

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Gemcitabine and carboplatin treatment in Patients with relapsing ovarian cancer

Šufliarský¹,

Chovanec²,

Světlovská³

et al. 2009

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Despite progress in primary treatment of patients with advanced ovarian cancer, the majority develop recurrence of the disease. A platinum salt treatment, either as monotherapy or in combination with another cytostatic agent, is indicated for patients who have relapsed 6 or more months after primary treatment and thus have platinum-sensitive relapse. Because repeated use of paclitaxel treatment may lead to substantial neurotoxicity, the combination of gemcitabine with carboplatin represents a suitable treatment option, which is widely used in common clinical practice in the Czech Republic and Slovakia.This non-interventional, prospective study observed the effectiveness and tolerability of second-line treatment with gemcitabine and carboplatin in patients with platinum-sensitive relapse of ovarian cancer in routine clinical practice. The primary endpoint was to evaluate the survival and secondary endpoints were to evaluate time to disease progression, objective tumor response rate, and treatment toxicity.Patients were enrolled to planned second-line treatment with gemcitabine and carboplatin (gemcitabine 1000 mg/m 2 and carboplatin AUC 5 on Day 1, and gemcitabine 1000 mg/m 2 on Day 8 of a 21-day cycle) for platinum-sensitive relapse of ovarian cancer as a part of routine clinical practice and followed for 12 months. The events (death, tumor progression), tumor response, and maximal grades of toxicity were recorded according to common clinical practice. Survival time (using Kaplan-Meier analysis) and objective tumor response rate were calculated using data forms, and a subgroup analysis was performed using log rank tests for time-to-event endpoints; p-values were also calculated. Response rates were calculated for the whole population; for the subgroups, the Fisher's exact test was performed and only p-values were calculated.Between January 2004 and June 2005, 53 patients were enrolled in the study. The median age was 57 years and 96% of patients had an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 and 1 at baseline. Approximately 91% of patients were originally diagnosed with stage III or IV; 60% of patients had disease free intervals (DFIs) of 12 or more months from previous therapy, and the additional 40% less than 12 months. The 1-year survival rate was 83%. Median survival time was not determined within the 12-month period following the start of the treatment study due to the limited duration of follow-up. Objective tumour response rate was 67.3%. Most common reasons for discontinuation of therapy were "Planned treatment completed" (53%) and "Tumor progression" (11%). Most common toxicities were leukopenia, anaemia, neutropenia, and thrombocytopenia; grades 3 and 4 of these toxicity types did not exceed 30%. Febrile neutropenia was recorded in two patients. Most common non-haematological toxicities were nausea and vomiting, fatigue, and neuropathy; grades 3 and 4 of these were below 6%. Results on time to disease progression are not published due to inconsistent statistical analysis of...

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A phase II study of gemcitabine plus carboplatin in platinum-sensitive, recurrent ovarian carcinoma

Cited by 30 publications

References 19 publications

Phase I clinical and pharmacokinetic study of trabectedin and carboplatin in patients with advanced solid tumors

Phase I clinical and pharmacokinetic study of trabectedin and carboplatin in patients with advanced solid tumors

Combination chemotherapy with carboplatin, capecitabine and epirubicin (ECarboX) as second- or third-line treatment in patients with relapsed ovarian cancer: a phase I/II trial

Gemcitabine and carboplatin treatment in Patients with relapsing ovarian cancer

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