Brief Title
Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
Official Title
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Tumor Response
Secondary Outcome
Time to Progression
Condition
Fallopian Tube Cancer
Intervention
capecitabine
Study Arms / Comparison Groups
Weekly Docetaxel and Capecitabine
Description: Weekly Docetaxel and Capecitabine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
2
Start Date
January 2006
Completion Date
July 2008
Primary Completion Date
May 2008
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Brigitte E. Miller, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00354601
Organization ID
CCCWFU-83203
Secondary IDs
CCCWFU-83203
Responsible Party
Sponsor
Study Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Brigitte E. Miller, MD, Study Chair, Wake Forest University Health Sciences
Verification Date
March 2017