Ovarian CarcinomaPhase 2NCT00183794
Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
A Phase 2 study testing Docetaxel and Gemcitabine in people with Ovarian Carcinoma and Peritoneal Neoplasms, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Peritoneal Neoplasms
- What is being tested?
- Docetaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
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.
Read the detailed description
Primary Objective:
- To determine the response rate, time to progression and survival (secondary) of the combination of docetaxel and gemcitabine administered on a weekly basis to patients with platinum-resistant ovarian cancer
Secondary Objective:
- To determine the toxicity of this combination regimen in patients with platinum-resistant ovarian cancer
- To evaluate the toxicity and safety profile of a short course (one dose) of premedication with steroids to patients receiving weekly gemcitabine and docetaxel
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Treatment repeats every 21 days until PD, unacceptable toxicity, or patient's withdrawal.
- Conditions
- Ovarian Carcinoma, Peritoneal Neoplasms
- Being tested
- Docetaxel and Gemcitabine
- Keywords
- Primary Peritoneal
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and GemcitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Docetaxel and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after enrollment of last participant
Secondary outcomes (1)
Median Time to Progression (Months)
Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)
Measured: 6 months after enrollment of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionMay 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Agustin Garcia, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183794
- Sponsor's protocol ID
- 5GYN-02-2
- Status last verified
- Dec 2012
- First submitted
- 9 Sep 2005
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00183794
- Acronym / sponsor ID
- 5GYN-02-2
- Conditions
- Ovarian Carcinoma, Peritoneal Neoplasms
- Keywords
- Primary Peritoneal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Eli Lilly and Company
- Study start
- Nov 2002
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 25 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
- To determine the response rate, time to progression and survival (secondary) of the combination of docetaxel and gemcitabine administered on a weekly basis to patients with platinum-resistant ovarian cancer
Secondary Objective:
- To determine the toxicity of this combination regimen in patients with platinum-resistant ovarian cancer
- To evaluate the toxicity and safety profile of a short course (one dose) of premedication with steroids to patients receiving weekly gemcitabine and docetaxel
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Treatment repeats every 21 days until PD, unacceptable toxicity, or patient's withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Docetaxel and GemcitabinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel and GemcitabineDocetaxel 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. | Drug | Arm 1 |
Primary outcome
Tumor Response Type: CR, PR, SD or PD
Time frame: 6 months after enrollment of last participant
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.
1 secondary outcome
Median Time to Progression (Months)
Time frame: 6 months after enrollment of last patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agustin Garcia, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Gemcitabine in people with Ovarian Carcinoma and Peritoneal Neoplasms, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response Type: CR, PR, SD or PD (time frame: 6 months after enrollment of last participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.