Topotecan Has Substantial Antitumor Activity as First-Line Salvage Therapy in Platinum-Sensitive Epithelial Ovarian Carcinoma: A Gynecologic Oncology Group Study

2000 ◽  
Vol 18 (5) ◽  
pp. 1062-1062 ◽  
Author(s):  
William P. McGuire ◽  
John A. Blessing ◽  
Michael A. Bookman ◽  
Samuel S. Lentz ◽  
Charles J. Dunton
Keyword(s):  
Ovarian Cancer ◽  
Active Drug ◽  
Response Rate ◽  
Gynecologic Oncology ◽  
Response Duration ◽  
Recurrent Ovarian Cancer ◽  
Hematologic Toxicity ◽  
Gynecologic Oncology Group ◽  
Median Response ◽  
Platinum Sensitive

PURPOSE: Topotecan is known to be active in recurrent ovarian cancer, but most prior studies have focused on platinum-resistant or refractory populations. This study was undertaken to define the response rate and progression-free interval in platinum-sensitive patients. PATIENTS AND METHODS: Patients with recurrent ovarian cancer after one or two prior chemotherapy regimens and in whom the interval between prior platinum therapy and the initiation of protocol therapy was greater than 6 months were treated with topotecan 1.5 mg/m2 intravenously over 30 minutes daily for 5 days, with this cycle repeated every 21 days. RESULTS: Forty-eight patients were entered onto the study; 47 were assessable for toxicity and 46 for response. The response rate was 33% (two complete responses and 13 partial responses), with a median response duration of 11.2 months. Hematologic toxicity predominated but was manageable in most patients with frequent incorporation of cytokines and RBC and platelet transfusions. Fatigue was reported in 15 patients and resulted in the discontinuation of therapy in five responding patients. CONCLUSION: Topotecan is an active drug in platinum-sensitive ovarian cancer, with significant but manageable hematologic toxicity. Fatigue is also a common problem that may be dose-limiting in some patients.

Gemcitabine and Vinorelbine Combination in Platinum-Sensitive Recurrent Ovarian Cancer

2009 ◽  
Vol 19 (9) ◽  
pp. 1529-1534 ◽  
Author(s):  
Annamaria Ferrero ◽  
Vilma Logrippo ◽  
Pier Giorgio Spanu ◽  
Luca Fuso ◽  
Stefania Perotto ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Response Rate ◽  
Response Duration ◽  
Recurrent Ovarian Cancer ◽  
Ca 125 ◽  
Cancer Antigen 125 ◽  
Median Response ◽  
Platinum Sensitive ◽  
Free Interval ◽  
Platinum Based Chemotherapy

Objectives:Most patients with ovarian cancer are candidates for second-line or salvage treatments often for prolonged periods. Patients with platinum-sensitive disease can benefit from a platinum retreatment with a likelihood of response dependents on the treatment-free interval. Alternative agents and combination chemotherapy are potential therapeutic approaches. At our institution, we carried out a phase II trial to evaluate feasibility, efficacy, and toxicity of gemcitabine and vinorelbine combination in recurrent ovarian carcinoma. The aim of the present study was to evaluate the role of this combination in patients with platinum-sensitive disease.Patients and Methods:Patients with platinum-sensitive disease recurring after 1 or more lines of platinum-based chemotherapy were included. Vinorelbine at 25 mg/m2followed by gemcitabine at 1000 mg/m2was administered intravenously on days 1 and 8 every 3 weeks. Response Evaluation Criteria in Solid Tumors and cancer antigen 125 test (CA-125 Kinetics [Rustin criteria]) were adopted to classify responses. Toxicity was assessed according to the National Cancer Institute Common Toxicity Criteria.Results:Thirty-nine patients were eligible. Platinum-free interval (PFI) was 6 to 12 months in 13 patients (33.3%; PFI 6-12) and more than 12 months in 26 patients (66.7%; PFI > 12). The overall response rate was 48.7%, with 6 complete responses. Median response duration was 38 weeks. The response rate was 23% in PFI 6-12 and 62% in PFI >12. The most frequently observed toxicity was hematological, with 23% of the patients having grade 3 or 4 neutropenia.Conclusions:Gemcitabine and vinorelbine combination is effective and well tolerated in recurrent platinum-sensitive ovarian cancer. It may represent an option in the management of these patients because the chronic nature of the disease.

scholarly journals Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer

2020 ◽  
Vol 16 (7) ◽  
pp. 225-246 ◽  
Author(s):  
Carolyn E Haunschild ◽  
Krishnansu S Tewari
Keyword(s):  
Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Double Blind ◽  
Free Survival ◽  
Platinum Sensitive ◽  
The Us ◽  
Us Fda

On 13 June 2018, Genentech, Inc. issued a press release announcing that the US FDA had approved the antiangiogenesis drug, bevacizumab, in combination with chemotherapy for frontline and maintenance therapy for women with newly diagnosed ovarian cancer. Regulatory approval was based on the National Cancer Institute-sponsored Gynecologic Oncology Group (GOG) protocol 0218, the Phase III, randomized, placebo-controlled, double-blind, multi-center and multi-national clinical trial that met its primary end point, progression-free survival. Bevacizumab is now approved in the frontline, platinum-sensitive recurrent and platinum-resistant recurrent settings for epithelial ovarian cancer. This review will address the broad range of clinical trials addressing the efficacy of bevacizumab use in ovarian cancer.

Phase II multicenter open-label study of karenitecin in previously treated epithelial ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study

2008 ◽  
Vol 18 (3) ◽  
pp. 460-464 ◽  
Author(s):  
J. J. KAVANAGH ◽  
M. W. SILL ◽  
P. T. RAMIREZ ◽  
D. WARSHAL ◽  
M. L. PEARL ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Topoisomerase I ◽  
Response Rate ◽  
Gynecologic Oncology ◽  
Complete Response ◽  
Gynecologic Oncology Group ◽  
Open Label ◽  
Peritoneal Cancer ◽  
Previously Treated

The topoisomerase I agents are established as a therapy in recurrent ovarian cancer. Karenitecin, an analog of topotecan with solubility and pharmacologic advantages, was tested in a phase II trial in previously treated patients with recurrent or persistent ovarian cancer. The drug was administered intravenously over 1 h at a dose of 1.0 mg/m2 daily for 5 days every 21 days. Patients were treated until disease progression, intolerable toxicity, or voluntary withdrawal. Response was evaluated according to modified RECIST criteria. Twenty-seven patients were entered into the study. One patient was inevaluable for not receiving any treatment. Of the 26 evaluable patients, there were two partial responses and one complete response for a total response rate of 12%. This response rate was insufficient to justify accrual to the second stage. The most common grade 3 or 4 toxicities were neutropenia (19%) and gastrointestinal (15%). Karenitecin is a well-tolerated topoisomerase compound but has minimal activity in extensively pretreated ovarian cancer with the dose-schedule employed.

Streptozocin plus fluorouracil versus doxorubicin therapy for metastatic carcinoid tumor.

1984 ◽  
Vol 2 (11) ◽  
pp. 1255-1259 ◽  
Author(s):  
P F Engstrom ◽  
P T Lavin ◽  
C G Moertel ◽  
E Folsch ◽  
H O Douglass
Keyword(s):  
Heart Disease ◽  
Carcinoid Tumor ◽  
Response Rate ◽  
Renal Toxicity ◽  
Response Duration ◽  
Hematologic Toxicity ◽  
Metastatic Carcinoid ◽  
Median Response ◽  
Prior Chemotherapy ◽  
Phase Ii And Iii

EST 5275 is a phase II and III study of fluorouracil plus streptozocin (5-FU plus STZ) or doxorubicin in patients with measurable progressive carcinoid tumor. Among one hundred seventy-two cases with no prior chemotherapy and no heart disease, the response rate was 22% for 5-FU plus STZ and 21% for doxorubicin, while the median response duration and median survival were 31 weeks and 64 weeks for the combination and 26 weeks and 48 weeks for doxorubicin. Thirty-three patients who failed 5-FU plus STZ crossed over to doxorubicin and achieved an 18% response. Of the thirty-five patients who failed on doxorubicin, 29% responded to 5-FU plus STZ. Hematologic toxicity was similar for both treatments; however, the 5-FU plus STZ patients experienced more vomiting but acceptable renal toxicity. Both chemotherapy regimens have antitumor activity in carcinoid tumors.

Phase II Evaluation of 24-h Continuous Infusion Topotecan in Recurrent, Potentially Platinum-Sensitive Ovarian Cancer: A Gynecologic Oncology Group Study

2000 ◽  
Vol 77 (1) ◽  
pp. 112-115 ◽  
Author(s):  
Maurie Markman ◽  
John A. Blessing ◽  
Ronald D. Alvarez ◽  
Parviz Hanjani ◽  
Steven Waggoner ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Gynecologic Oncology ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Oncology Group Study ◽  
Platinum Sensitive

GOG0076-GG: A limited access phase II trial of pemetrexed (LY231514) (NSC #698037) in combination with cisplatin (NSC #119875) in the treatment of advanced, persistent, or recurrent carcinoma of the cervix—A Gynecologic Oncology Group study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5527-5527
Author(s):  
David S. Miller ◽  
John A. Blessing ◽  
Lois M. Ramondetta ◽  
Huyen Pham ◽  
Krishnansu Sujata Tewari ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Tumor Response ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Response Duration ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Median Response ◽  
Recurrent Carcinoma ◽  
Common Grade

5527 Background: To estimate the antitumor activity of Pemetrexed and cisplatin with objective tumor response (partial and complete) in patients with advanced, persistent, or recurrent carcinoma of the cervix and to determine the nature and degree of toxicity of this regimen. Secondarily, to determine the effects of this regimen on progression-free survival and overall survival. Methods: Eligible, consenting patients received pemetrexed 500mg/m2 and cisplatin 50 mg/m2 IV repeated every 21 days until disease progression or adverse effects prohibited further therapy. Patients had received no prior therapeutic chemotherapy, except when administered concurrent with primary radiation therapy. Subsequent doses were adjusted according to observed toxicity and protocol guidelines. Adverse events were assessed with CTCAE v 3.0. Primary measure of efficacy was tumor response by RECIST. The study was stratified by prior radiation therapy. Results: From September 2008 to November 2011, 55 patients were enrolled by 5 GOG member institutions. Of those, 49 patients were eligible and assessable. The regimen was well tolerated with 14 (29%) receiving >9 cycles. Common grade >2 toxicities were neutropenia 35%, leukopenia 28%, and metabolic 28%. The overall response rate was 31% (one complete and 16 partial responses). The median response duration was 7 months and survival 12 months. Conclusions: Pemetrexed in combination with cisplatin has demonstrated activity in the treatment of advanced, persistent, or recurrent carcinoma of the cervix. Additional study of this regimen in a phase III setting is justified in this patient population. Clinical trial information: NCT00691301.

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