Phase 2 N=20 Treatment

Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma

Ovarian Carcinoma · Peritoneal Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00183794 ↗

Enrolled (actual)

Serious AEs

60.0%

Results posted

Jan 2013

Primary outcome: Primary: Tumor Response Type: CR, PR, SD or PD — 1; 4; 9; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Docetaxel and Gemcitabine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Southern California
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Tumor Response Type: CR, PR, SD or PD	1; 4; 9; 6	—
SECONDARY Median Time to Progression (Months)	3	—

Summary

This study is for patients with advanced ovarian cancer that has reappeared after treatment with conventional therapy. The purpose of this study is to determine if the combination of docetaxel and gemcitabine will be effective in reducing or eliminating the tumor(s) in patients with ovarian cancer. Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer. Both drugs have been shown to decrease the size of ovarian cancer tumors.

Eligibility Criteria

Inclusion Criteria

Histologically proven diagnosis of epithelial ovarian ca
Must have platinum-resistant disease. (Defined as progression during the most recent platinum-based chemotx or relapse 1.5 x uln and alkaline phosphatase > 2.5 x uln, patient is not eligible.)
Fully recovered from acute toxicities secondary to prior treatment (tx)
Signed informed consent

Exclusion Criteria

Prior treatment with gemcitabine or docetaxel
Underlying medical, psychiatric, or social conditions that would preclude patient from receiving treatment
Peripheral neuropathy greater than or equal to Grade 2
No prior tx with cisplatin or carboplatin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00183794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.