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A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum



- Determine the response rate in patients with recurrent or persistent ovarian epithelial
cancer, fallopian tube cancer, or peritoneal cavity cancer treated with docetaxel and


- 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.

Inclusion Criteria:


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Tumor Response

Outcome Description:

The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Brigitte E. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

July 2008

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • 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
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096