Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer

Wake Forest University (WFU)

Status and phase

Terminated

Phase 2

Conditions

Fallopian Tube Cancer

Peritoneal Cavity Cancer

Ovarian Cancer

Treatments

Drug: docetaxel

Drug: capecitabine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00354601

CCCWFU-BG05-536

CCCWFU-83203

ROCHE-CCCWFU-BG05-536

AVENTIS-CCCWFU-83203

CDR0000489036

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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