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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00354601
Recruitment Status : Terminated (funding withdrawn)
First Posted : July 20, 2006
Results First Posted : May 18, 2009
Last Update Posted : August 30, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Drug: capecitabine Drug: docetaxel Phase 2

Detailed Description:



  • 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.


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: Weekly Docetaxel and Capecitabine
Weekly Docetaxel and Capecitabine
Drug: capecitabine
oral capecitabine twice daily on days 1-21
Drug: docetaxel
docetaxel IV over 30 minutes on days 1, 8, and 15

Primary Outcome Measures :
  1. Objective Tumor Response [ Time Frame: 8 weeks ]
    The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines

Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: 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

  2. Number of Participants With Grade 3 or Higher Toxicity [ Time Frame: 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.

  3. Quality of Life [ Time Frame: Pre-entry, day 1, treatment end ]
    comparison of treatment end to pre entry and day 1 of each treatment cycle.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00354601

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Brigitte E. Miller, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00354601     History of Changes
Other Study ID Numbers: CCCWFU-83203
First Posted: July 20, 2006    Key Record Dates
Results First Posted: May 18, 2009
Last Update Posted: August 30, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic