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

NCT02026921 | Completed Phase 2

• 1 other identifier: NSGO-OC-0303
• Study Type: interventional
• Target: 74
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Ovarian Epithelial Cancer Recurrent

Keywords

Phase II study,; Recurrent platinum-sensitive ovarian cancer; docetaxel; Carboplatin; Toxicity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Response rate

  Up to 30 dayes after last chemotherapy course

• Progression free survival

  Up to 3 year

Study Arms (1)

Carboplatin and docetaxel

EXPERIMENTAL

Intravenous infusion every 3 weeks Carboplatin plus docetaxel

Drug: Carboplatin; Drug: Docetaxel

Interventions

Carboplatin DRUG

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

Carboplatin and docetaxel

Docetaxel DRUG

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.

Also known as: Taxotere

Carboplatin and docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead

Study Sites (4)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Herlev University Hospital

Copenhagen, 2730, Denmark

Location

Tampere University Hospital

Tampere, Finland

Location

Norwegian Radium Hospital

Oslo, 0310, Norway

Location

MeSH Terms

Interventions

Carboplatin; Docetaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Gunnar B Kristensen, MD, PhD

  NSGO-CTU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 3, 2014
• Study Start: June 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: December 1, 2008
• Last Updated: January 3, 2014

Record last verified: 2013-12

Locations

NO (1); FI (1); DK (2)