Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Conditions
Keywords
fallopian tube cancer, peritoneal cavity cancer, recurrent ovarian epithelial cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
Detailed description
OBJECTIVES: Primary * Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer treated with docetaxel and capecitabine. Secondary * Determine the time to progression in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine the quality of life during treatment of these patients. OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for ≥ 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on day 1 of each course, and then at completion of study treatment. After completion of study treatment, patients are followed every 2-3 months.
Interventions
DRUGcapecitabine
oral capecitabine twice daily on days 1-21
DRUGdocetaxel
docetaxel IV over 30 minutes on days 1, 8, and 15
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Ovarian epithelial adenocarcinoma * Fallopian tube cancer * Peritoneal cavity cancer * Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease) * Platinum-resistant disease, defined as 1 of the following: * Treatment-free interval \< 6 months after platinum-based therapy * Disease progression during platinum-based therapy * Measurable disease by physical exam, chest x-ray, CT scan, or MRI * No brain metastases PATIENT CHARACTERISTICS: * Gynecologic Oncology Group performance status 0-2 * Life expectancy \> 6 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8 g/dL * Creatinine clearance ≥ 50 mL/min * Bilirubin normal * AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria: * AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal * AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN * AST or ALT normal AND AP ≤ 5 times ULN * No peripheral neuropathy \> grade 2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No other concurrent malignancy except for curatively treated nonmelanoma skin cancer * No prior invasive malignancy \< 5 years after curative therapy * No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to \< 6 months * No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil * No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome * No serious concurrent infections * No clinically significant cardiac disease not well controlled with medication, including any of the following: * Congestive heart failure * Symptomatic coronary artery disease * Symptomatic cardiac arrhythmias * Myocardial infarction within the past 12 months PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior docetaxel or capecitabine or other fluoropyrimidine therapy * Recovered from prior therapy * At least 2 weeks since prior major surgery * At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy * No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Tumor Response | 8 weeks | The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | Evaluated every 8 weeks during treatment | Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter |
| Number of Participants With Grade 3 or Higher Toxicity | Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy) | summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom. |
| Quality of Life | Pre-entry, day 1, treatment end | comparison of treatment end to pre entry and day 1 of each treatment cycle. |
Countries
United States
Participant flow
Recruitment details
Patients enrolled 01/23/2006 to 03/16/2007 at which time the protocol was suspended for lack of funding
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel and Capecitabine Docetaxel and Capecitabine therapy per protocol | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | progression | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Docetaxel and Capecitabine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 60.15 years STANDARD_DEVIATION 8.84 |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 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 | 2 / — |
| serious Total, serious adverse events | 1 / — |
Outcome results
Primary
Objective Tumor Response
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
Time frame: 8 weeks
Population: unable to measure due to failure to complete
Secondary
Number of Participants With Grade 3 or Higher Toxicity
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
Time frame: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
Population: tracked during incomplete treatment period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel and Capecitabine | Number of Participants With Grade 3 or Higher Toxicity | 1 participants |
Secondary
Quality of Life
comparison of treatment end to pre entry and day 1 of each treatment cycle.
Time frame: Pre-entry, day 1, treatment end
Population: neither patient completed study
Secondary
Time to Progression
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
Time frame: Evaluated every 8 weeks during treatment
Population: unable to analyze due to failure to complete treatment or study