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

This study has been terminated.
(funding withdrawn)
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00354601
First received: July 19, 2006
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: capecitabine
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Objective Tumor Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines


Secondary Outcome Measures:
  • Time to Progression [ Time Frame: Evaluated every 8 weeks during treatment ] [ Designated as safety issue: No ]
    Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter

  • 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) ] [ Designated as safety issue: Yes ]
    summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.

  • Quality of Life [ Time Frame: Pre-entry, day 1, treatment end ] [ Designated as safety issue: No ]
    comparison of treatment end to pre entry and day 1 of each treatment cycle.


Enrollment: 2
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: capecitabine
    oral capecitabine twice daily on days 1-21
    Drug: docetaxel
    docetaxel IV over 30 minutes on days 1, 8, and 15
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354601

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Brigitte E. Miller, MD Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Brigitte E. Miller, Wake Forest University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00354601     History of Changes
Other Study ID Numbers: CCCWFU-83203, CCCWFU-83203, CCCWFU-BG05-536, AVENTIS-CCCWFU-83203, CDR0000489036, ROCHE-CCCWFU-BG05-536
Study First Received: July 19, 2006
Results First Received: March 9, 2009
Last Updated: January 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014