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A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01851746
Recruitment Status : Unknown
Verified May 2013 by HB Cai, Wuhan University.
Recruitment status was:  Active, not recruiting
First Posted : May 10, 2013
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
HB Cai, Wuhan University

Brief Summary:
The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.

Condition or disease
Recurrent Ovarian Cancer

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Study of Docetaxel and Lobaplatin vs. Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer
Study Start Date : March 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015





Primary Outcome Measures :
  1. Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer. [ Time Frame: from pre-chemotherapy to 4-6 weeks post-chemotherapy ]
    Blood routine, urine routine, hepatic and kidney function, electrolyte, ECG, CT,MRI


Biospecimen Retention:   Samples Without DNA
Boold,Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
residents of a certain town
Criteria

Inclusion Criteria:

  1. age between 18 and 70 years old
  2. singed the information consent form
  3. Expected survival time >3 months
  4. Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications.

Exclusion Criteria:

  1. Recurrence within 6 months after receiving initial platinum-based chemotherapy
  2. without radiographic evidence for tumor recurrence
  3. receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851746


Locations
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China, Hubei
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Sponsors and Collaborators
Wuhan University
Investigators
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Study Director: Hong-bing Cai, MD,PhD Wuhan University

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Responsible Party: HB Cai, Director of gynecologic oncology department of Zhongnan Hospital of Wuhan University, Wuhan University
ClinicalTrials.gov Identifier: NCT01851746     History of Changes
Other Study ID Numbers: CHB2013
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013
Keywords provided by HB Cai, Wuhan University:
recurrent ovarian cancer
lobaplatin
docetaxel
carboplatin
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action