A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer

Ovarian Epithelial Cancer Recurrent Clinical Trial

Official title:

A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026921
• Other study ID #: NSGO-OC-0303
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2013
• Last updated: December 31, 2013
• Start date: June 2004
• Est. completion date: December 2008

Study information

• Verified date: December 2013
• Source: Nordic Society for Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer.

Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.

Description:

Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin.

• Female

• age above 18 years

• WHO performance status 0-2

• Life expectancy > 3 months

• Previous treatment with one platinum and taxane containing regimen.

• Platinum and taxane sensitive relapse

• At least one evaluable/measurable lesion.

• Adequate hematologic, renal and liver function

• Consent form signed and dated before inclusion

Exclusion Criteria:

• Prior treatment with more than one line of chemotherapy

• Concurrent severe and/or uncontrolled co-morbid medical condition.

• History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock

• Pregnant or lactating women (or potentially fertile women not using adequate contraception)

• Peripheral neuropathy > Grade 2

• History of allergy to drugs containing the excipient TWEEN 80®.

• Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy

• Clinical evidence of brain metastases

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Epithelial Cancer Recurrent
• Ovarian Neoplasms

Intervention

Drug:
• Carboplatin
Carboplatin, AUC5, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops
• Docetaxel
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Herlev University Hospital	Copenhagen
Finland	Tampere University Hospital	Tampere
Norway	Norwegian Radium Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Society for Gynaecologic Oncology

Countries where clinical trial is conducted

Denmark,  Finland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 2.0). All toxicities observed within 30 dayes of last chemocourse will be included.	Up to 30 days after last chemotherapy course	Yes
Secondary	Response rate	Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR.	Up to 30 dayes after last chemotherapy course	No
Secondary	Progression free survival	Time from start of treatment to the earlier date of assessment of progression or death by any cause.	Up to 3 year	No