Clinical trial NCT00354601: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-07-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Tumor Response
timeFrame: 8 weeks
Secondary outcomes:
measure: Time to Progression
timeFrame: Evaluated every 8 weeks during treatment
measure: Number of Participants With Grade 3 or Higher Toxicity
timeFrame: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
measure: Quality of Life
timeFrame: Pre-entry, day 1, treatment end
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brigitte E. Miller, MD
role: STUDY_CHAIR
References: