Fallopian Tube Cancer, Mixed Tumor, Mesodermal, Ovarian Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
carboplatin, paclitaxel, elderly women
Brief summary
The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.
Detailed description
OBJECTIVES: Primary •To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities. Secondary * Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients * Assess significant toxicities in this group of patients and compare to a non-elderly population. * To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy. * Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy. * Assess progression-free survival and overall survival for this group. * To determine the feasibility of accrual. STATISTICAL DESIGN: Using a one sample binomial design, with 37 patients there was 83% power to detect a null hypothesis of a 45% therapy completion rate versus an alternative hypothesis of a 66% rate assuming a one-sided 5% alpha. The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments.
Interventions
DRUGPaclitaxel
DRUGCarboplatin
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 70 or older * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy * Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus * Life expectancy greater than 6 months * Baseline laboratory values as described in protocol
Exclusion criteria
* Active infection requiring antibiotics at the time of starting chemotherapy * Prior pelvic radiotherapy \> 25% of bone marrow * Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs * Past history of bone marrow transplantation or stem cell support * Known history of central nervous system (CNS) metastasis * History of prior malignancy that required prior systemic therapy * Clinically significant cardiac disease * Uncontrolled diabetes mellitus * Any signs of intestinal obstruction * Participation in an investigational drug study within three weeks prior to study entry * History of psychiatric disability or other central nervous system disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapy Completion Rate | 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days. | The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions. |
Countries
United States
Participant flow
Recruitment details
12 patients were enrolled between March 26, 2006 and January 2, 2008.
Participants by arm
| Arm | Count |
|---|---|
| Carboplatin/Paclitaxel Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 2 |
| Overall Study | Disease Progression | 2 |
Baseline characteristics
| Characteristic | Carboplatin/Paclitaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 78.3 years |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 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 | 9 / 12 |
| serious Total, serious adverse events | 5 / 12 |
Outcome results
Primary
Therapy Completion Rate
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
Time frame: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Population: The analysis dataset is comprised of all treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carboplatin/Paclitaxel | Therapy Completion Rate | .50 proportion of participants |