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

NCT00183794 | Completed Phase 2 Results

• 1 other identifier: 5GYN-02-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Carcinoma; Peritoneal Neoplasms

Keywords

Primary Peritoneal

Outcome Measures

Primary Outcomes (1)

• Tumor Response Type: CR, PR, SD or PD

  Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= \<30% decrease or \<20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.

  6 months after enrollment of last participant

Secondary Outcomes (1)

• Median Time to Progression (Months)

  6 months after enrollment of last patient

Study Arms (1)

Arm 1

EXPERIMENTAL

Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.

Drug: Docetaxel and Gemcitabine

Interventions

Docetaxel and Gemcitabine DRUG

Docetaxel 75 mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8 of each 3 weeks (21 days) cycle.

Arm 1

Eligibility Criteria

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

You may qualify if:

• Histologically proven diagnosis of epithelial ovarian ca
• Must have platinum-resistant disease. (Defined as progression during the most recent platinum-based chemotx or relapse \< 6 months after the most recent platinum-based chemotx regimen.)
• Measurable or evaluable disease. (Patients whose dz is manifested only as an elevated CA-125 \[greater than or equal to 100\] are eligible. If an elevated CA-125 is the only manifestation of dz, it must be confirmed on 2 separate times, at least 2 weeks apart. Patients with positive cytology only are not eligible.)
• Greater than or equal to 18 years of age
• GOG performance status less than or equal to 2
• AGC/ANC greater than or equal to 1.5; platelets greater than or equal to 100,000; hemoglobin (Hgb) greater than or equal to 8.0.
• Creatinine less than or equal to 2.0
• Total bilirubin less than or equal to upper limit of normal (uln)
• SGOT and/or SGPT less than or equal to 2.5 x uln if alkaline phosphatase less than or equal to uln, or alkaline phosphatase less than or equal to 4 x uln if transaminases are less than or equal to uln. (If both SGOT/SGPT \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Aventis Pharmaceuticals: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Peritoneal Neoplasms

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Agustin Garcia, MD
• Organization: USC/Norris Cancer Comprehensive Cancer Center

aagarcia@usc.edu

323-865-3900

Study Officials

• Agustin Garcia, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2002
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: May 22, 2014
• Results First Posted: January 25, 2013

Record last verified: 2012-12

Locations

US (1)