Ovarian Carcinoma, Peritoneal Neoplasms
Conditions
Keywords
Primary Peritoneal
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.
Detailed description
Primary Objective: 1\. 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: 1. To determine the toxicity of this combination regimen in patients with platinum-resistant ovarian cancer 2. 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.
Interventions
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.
Sponsors
Aventis Pharmaceuticals
Eli Lilly and Company
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \< 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Type: CR, PR, SD or PD | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Progression (Months) | 6 months after enrollment of last patient | 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) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the USC+LAC Women's Hospital and the USC/Norris Cancer Hospital between December 2002 and April 2008.
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine and Docetaxel 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Gemcitabine and Docetaxel |
|---|---|
| Age, Continuous Between 43 and 75 years | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 20 |
| serious Total, serious adverse events | 12 / 20 |
Outcome results
Primary
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.
Time frame: 6 months after enrollment of last participant
Population: Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine and Docetaxel | Tumor Response Type: CR, PR, SD or PD | PD | 6 Participants |
| Gemcitabine and Docetaxel | Tumor Response Type: CR, PR, SD or PD | CR | 1 Participants |
| Gemcitabine and Docetaxel | Tumor Response Type: CR, PR, SD or PD | PR | 4 Participants |
| Gemcitabine and Docetaxel | Tumor Response Type: CR, PR, SD or PD | SD | 9 Participants |
Secondary
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)
Time frame: 6 months after enrollment of last patient
Population: All participants who receive the first course of treatment are included in the summary of PFS.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine and Docetaxel | Median Time to Progression (Months) | 3 Months |