Docetaxel and oxaliplatin in the second-line treatment of platinum-sensitive recurrent ovarian cancer: a phase II study

PURPOSE Topotecan is a topoisomerase I inhibitor with preclinical activity against various tumor types. We conducted a large multicenter phase II study with topotecan in ovarian cancer in patients who had failed to respond to one prior cisplatin-based chemotherapeutic regimen. PATIENTS AND METHODS Topotecan 1.5 mg/m2/d was administered intravenously by 30-minute infusion for 5 days repeated every 3 weeks. As the cisplatin-free interval relates to response in subsequent treatment, patients were stratified in subgroups, ie, cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive. RESULTS One-hundred eleven patients entered the study. Nineteen patients were considered to be ineligible; 92 patients were assessable for response. A total of 552 courses were given (median, four per patient; range, one to 17). The major toxicities were leukocytopenia and neutropenia, which were grade 3 to 4 in 54.2% and 69.1% of courses, respectively, but with only 4.3% of these being grade 4 neutropenia plus fever or infectious complications. Prophylactic granulocyte colony-stimulating factor (G-CSF) was given in 20.5% of courses to maintain dose-intensity. Other relatively frequent side effects were alopecia (82%), nausea (36.4%), and vomiting (17.5%). The overall response rate was 16.3%, with one complete response (CR) and 14 partial responses (PRs). In the cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive strata, the response rates were 5.9%, 17.8%, and 26.7%, respectively. The median duration of time of documented response was 21.7 weeks (range, 4.6 to 41.9). CONCLUSION Topotecan in a daily-times-five schedule is an effective regimen as second-line treatment in ovarian cancer. Further investigations of topotecan in ovarian cancer, including first-line use and combination with other active agents, are indicated.

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Phase II study of DMXAA combined with carboplatin and paclitaxel in recurrent ovarian cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.5032 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 5032-5032 ◽

Cited By ~ 6

Author(s):

H. Gabra

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Stable Disease ◽

Phase Ii Study ◽

Objective Response ◽

Recurrent Ovarian Cancer ◽

Figo Stage ◽

Vascular Disrupting Agent ◽

Platinum Sensitive ◽

Platinum Based Chemotherapy

5032 Background: DMXAA (AS1404) is a small-molecule vascular disrupting agent, which in animal models shows additive or supra-additive effects with cytotoxics, including taxanes and platinum agents. This phase II study evaluated DMXAA in combination with carboplatin and paclitaxel in recurrent platinum-sensitive ovarian cancer patients with a progression-free interval of more than 6 months after response to platinum-based chemotherapy. Methods: Patients had first diagnosed disease FIGO stage Ic-IV, with presence of recurrent disease confirmed by imaging. Patients were randomised 1:1 to receive up to 6 cycles of carboplatin (AUC 6 mg/ml × min) and paclitaxel (175 mg/m2) with or without DMXAA (1200 mg/m2). Safety assessments included EKG, adverse events, laboratory screens and ophthalmic exam. Efficacy endpoints are objective response rates, time to progression, duration of response and stable disease, and median and 1-year survival. Results: 55 patients have been enrolled to date from a planned total of ∼70. Initial safety findings in the two arms are comparable. Preliminary investigator-assessed RECIST response data show the following unconfirmed outcomes: of 17 patients in the DMXAA arm, there are 10 with partial responses (PRs), 7 with stable disease (SD) and 0 with progressive disease (PD); of 14 patients in the control arm, there are 8 PRs, 6 SDs and 0 PDs. Conclusions: Initial safety findings suggest that addition of DMXAA to standard doses of carboplatin and paclitaxel did not add significantly to toxicity. Efficacy assessments are ongoing to determine the value of the triple combination in recurrent ovarian cancer. No significant financial relationships to disclose.

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A single-arm phase II study of olaparib maintenance with pembrolizumab and bevacizumab in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer (OPEB-01)

Journal of Gynecologic Oncology ◽

10.3802/jgo.2021.32.e31 ◽

2021 ◽

Vol 32 (2) ◽

Author(s):

Yong Jae Lee ◽

Myong Cheol Lim ◽

Byoung-Gie Kim ◽

Natalie YL Ngoi ◽

Chel Hun Choi ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Recurrent Ovarian Cancer ◽

Platinum Sensitive

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Second-Line Treatment with Intravenous Gemcitabine and Oral Etoposide in Platinum-Resistant Advanced Ovarian Cancer Patients: Results of a Phase II Study

Oncology ◽

10.1159/000328451 ◽

2011 ◽

Vol 80 (3-4) ◽

pp. 238-246 ◽

Cited By ~ 6

Author(s):

M. Bruzzone ◽

M.G. Centurioni ◽

P. Giglione ◽

M. Gualco ◽

D.F. Merlo ◽

...

Keyword(s):

Ovarian Cancer ◽

Cancer Patients ◽

Phase Ii ◽

Phase Ii Study ◽

Advanced Ovarian Cancer ◽

Oral Etoposide ◽

Line Treatment ◽

Second Line ◽

Platinum Resistant

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A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer

Gynecologic Oncology ◽

10.1016/j.ygyno.2014.05.030 ◽

2014 ◽

Vol 134 (2) ◽

pp. 262-266 ◽

Cited By ~ 9

Author(s):

Eric L. Eisenhauer ◽

Vanna Zanagnolo ◽

David E. Cohn ◽

Ritu Salani ◽

David M. O'Malley ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Recurrent Ovarian Cancer ◽

Platinum Sensitive

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A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer

Gynecologic Oncology ◽

10.1016/j.ygyno.2010.12.076 ◽

2011 ◽

Vol 120 ◽

pp. S31

Author(s):

E. Eisenhauer ◽

V. Zanagnolo ◽

D. Cohn ◽

R. Salani ◽

D. O'Malley ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Recurrent Ovarian Cancer ◽

Platinum Sensitive

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Secondary Cytoreduction and Carboplatin Hyperthermic Intraperitoneal Chemotherapy for Platinum-Sensitive Recurrent Ovarian Cancer: An MSK Team Ovary Phase II Study

Journal of Clinical Oncology ◽

10.1200/jco.21.00605 ◽

2021 ◽

pp. JCO.21.00605

Author(s):

Oliver Zivanovic ◽

Dennis S. Chi ◽

Qin Zhou ◽

Alexia Iasonos ◽

Jason A. Konner ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Intraperitoneal Chemotherapy ◽

Cytoreductive Surgery ◽

Hyperthermic Intraperitoneal Chemotherapy ◽

Phase Ii Study ◽

Recurrent Ovarian Cancer ◽

Hazard Ratio ◽

Platinum Sensitive ◽

Secondary Cytoreductive Surgery

PURPOSE The purpose of this phase II study was to evaluate hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin for recurrent ovarian cancer during secondary cytoreductive surgery. MATERIALS AND METHODS Patients were intraoperatively randomly assigned to carboplatin HIPEC (800 mg/m2 for 90 minutes) or no HIPEC, followed by five or six cycles of postoperative IV carboplatin-based chemotherapy, respectively. Based on a binomial single-stage pick-the-winner design, an arm was considered winner if ≥ 17 of 49 patients were without disease progression at 24 months post-surgery. Secondary objectives included postoperative toxicity and HIPEC pharmacokinetics. RESULTS Of 98 patients, 49 (50%) received HIPEC. Complete gross resection was achieved in 82% of the HIPEC patients and 94% of the standard-arm patients. Bowel resection was performed in 37% of patients in the HIPEC arm compared with 65% in the standard ( P = .008). There was no perioperative mortality and no difference in use of ostomies, length of stay, or postoperative toxicity. At 24 months, eight patients (16.3%; 1-sided 90% CI, 9.7 to 100) were without progression or death in the HIPEC arm and 12 (24.5%; 1-sided 90% CI, 16.5 to 100) in the standard arm. With a medium follow-up of 39.5 months, 82 patients progressed and 37 died. The median progression-free survival in the HIPEC and standard arms were 12.3 and 15.7 months, respectively (hazard ratio, 1.54; 95% CI, 1 to 2.37; P = .05). There was no significant difference in median overall survival (52.5 v 59.7 months, respectively; hazard ratio, 1.39; 95% CI, 0.73 to 2.67; P = .31). These analyses were exploratory. CONCLUSION HIPEC with carboplatin was well tolerated but did not result in superior clinical outcomes. This study does not support the use of HIPEC with carboplatin during secondary cytoreductive surgery for platinum-sensitive recurrent ovarian cancer.

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