Symptoms and General Pathology

All Conditions

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Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Fallopian Tube Neoplasms

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Quality of Life

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice

Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection

Tumor Debulking Surgery (surgery in recurrent ovarian disease)

Philipp Harter, MD

It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.

A predictive score identifying patients who might achieve a complete resection is deemed necessary to select the right patients for a prospective trial on cytoreductive surgery in relapsed ovarian cancer.

Study centres are selected due to their surgical experience in ovarian cancer and/or participation in prior surgical trials in this field. Patients who matched eligibility criteria were allocated randomly 1:1 prospectively to cytoreductive surgery followed by platinum based combination chemotherapy or to platinum based combination chemotherapy alone .

Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score

patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score

Composite of 27 items regarding physical, functional, social/family and emotional well-being. from 0-108

Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44

Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152

ARCAGY/ GINECO GROUP

Grupo Español de Investigación en Cáncer de Ovario

Cancer Research UK

Shanghai Gynecologic Oncology Group

AGO Study Group

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Anti-Infective Agents

Paclitaxel

Tamoxifen

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Taxane

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Tamoxifen 40 mg is given orally once daily until progression

Paclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression

Paclitaxel or pegylated liposomal doxorubicin

Chemotherapy

Gunnar B Kristensen, Prof

A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.

Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).

Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane

A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Amino Acids

Sunitinib

Tyrosine Kinase Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Tyrosine

Subjects will receive open-label sunitinib = SU11248 at a dose of 50.0 mg once daily. After 28 days, treatment will be paused for 14 days and cycle one is completed, followed by resumption of therapy as cycle one for up to one year (therapy can be continued in case of tumor response and benefit for the patient for more than one year).

Subjects will receive open-label sunitinib = SU11248 at a dose of 37.5 mg once daily continuously. Treatment period up to one year (therapy can be continued in case of tumor response and benefit for the patient for more than one year).

Sunitinib, oral, 50mg once daily, 28 days then paused for 14 days, for up to one year

Sunitinib, oral, 37,5 mg once daily continuously, up to one year

SUNITINIB

Uwe Wagner, MD, PhD

Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic strategies consist of a platinum containing chemotherapy subsequent to primary surgery. Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant number of patients will show tumor progression during first line chemotherapy or relapse within six months after completion of first line chemotherapy, therefore being characterized as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of overall response, underlining the poor prognosis for these patients with an estimated median overall survival of 20 weeks.

In addition to conventional chemotherapeutics, so called small molecules are of high interest to establish new strategies in chemotherapy-refractory ovarian cancer (and in the long run first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.

SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical trials have been initiated in other tumor entities. Growth pattern and biological targets present in ovarian cancer indicate that SU11248 might be a promising compound for the treatment of ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for SU11248, which are expressed in ovarian cancer. The different targets of SU11248 provide a potential advantage of this compound compared to single-target molecules in chemotherapy-refractory ovarian cancer.

This study in patients with ovarian cancer refractory to platinum based chemotherapy is designed as a randomized, 2-schedule and dose-level, open-label, multicenter phase II study to select the better dose and schedule arm for further investigation.

72 patients will be randomized in a 1:1 ratio to receive oral SU11248 therapy either 37.5 mg/day continuously or 50mg/day for 4 weeks followed by 14 days off.

Patients will get outpatients treatment. At screening the patients' eligibility will be assessed, their baseline and demographic characteristics obtained, and the baseline values for the effect variables collected. Patients with measurable lesions as well as non-measurable disease will be included into this trial. Measurable lesion will be documented by CT or MRI scan and CA-125 values, non-measurable lesions will be monitored by analysis of CA°125 levels.

The patients' safety will be monitored during and up to 30 days after termination of SU11248 therapy.

In patients with measurable lesions at baseline, the (post)-treatment values for effect according to the RECIST criteria will be collected as shown in table 6. In case of CR or PR, a confirmatory CT or MRI scan is required after an interval of at least four weeks. Antitumor effects according to CA°125 levels will be determined in the same time intervals and, in addition, 28 days after last SU11248 application in patients with CA°125 response according to GCIG guidelines during therapy.

For post study follow-up, patients and/or their physicians will be contacted via phone for overall survival and TTP (including the method of diagnosis and additional treatment) every 2 months for their life time.

Randomized Multicenter Trial With SU11248 Evaluating Dosage,Tolerability,Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor

Phase II Trial in Platinum-refractory Ovarian Cancer: A Randomized Multicenter Trial With SU11248 to Evaluate Dosage, Tolerability, Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor Monotherapy

Philipps University Marburg Medical Center

HSK Reasearch GmbH Wiesbaden

Gefitinib

ZD1839

tamoxifen

Uwe Wagner, Prof.Dr.

Although initially responsive to cytoreductive surgery and platinum- and/or taxane-based chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum will eventually relapse. Recurrence within 6 months after completing platinum-containing chemotherapy indicates a platinum-refractory cancer disease. New therapeutic strategies are required in platinum-refractory disease. Inhibition of growth signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum. The trial is to evaluate the safety and tolerability of the combination of the epidermal growth facto tyrosine kinase inhibitor ZD1839 and the clinically established antiestrogen tamoxifen.

A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer	NCT01166737	Fallopian Tube ... Ovarian Cancer Peritoneal Cavi...	Tumor Debulking...	18 Years -	AGO Study Group
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane	NCT02728622	Ovarian Cancer Peritoneal Canc... Cancer of the F...	Tamoxifen Chemotherapy	18 Years -	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Randomized Multicenter Trial With SU11248 Evaluating Dosage,Tolerability,Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor	NCT00543049	Platinum Refrac... Primary Cancer ... Cancer of the F...	Sunitinib SUNITINIB	18 Years -	AGO Study Group
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane	NCT02728622	Ovarian Cancer Peritoneal Canc... Cancer of the F...	Tamoxifen Chemotherapy	18 Years -	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane	NCT02728622	Ovarian Cancer Peritoneal Canc... Cancer of the F...	Tamoxifen Chemotherapy	18 Years -	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer	NCT01166737	Fallopian Tube ... Ovarian Cancer Peritoneal Cavi...	Tumor Debulking...	18 Years -	AGO Study Group
A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy	NCT00189358	Ovarian Cancer Cancer of the F... Peritoneal Canc...	ZD1839 tamoxifen	18 Years -	AGO Study Group

Spots Global Cancer Trial Database for cancer of the fallopian tube