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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
docetaxel
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weekly Docetaxel and Capecitabine

Arm Description

Weekly Docetaxel and Capecitabine

Outcomes

Primary Outcome Measures

Objective Tumor Response
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
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
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
comparison of treatment end to pre entry and day 1 of each treatment cycle.

Full Information

First Posted
July 19, 2006
Last Updated
July 31, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00354601
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
funding withdrawn
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weekly Docetaxel and Capecitabine
Arm Type
Experimental
Arm Description
Weekly Docetaxel and Capecitabine
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
oral capecitabine twice daily on days 1-21
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
docetaxel IV over 30 minutes on days 1, 8, and 15
Primary Outcome Measure Information:
Title
Objective Tumor Response
Description
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Time to Progression
Description
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
Time Frame
Evaluated every 8 weeks during treatment
Title
Number of Participants With Grade 3 or Higher Toxicity
Description
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
Time Frame
Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
Title
Quality of Life
Description
comparison of treatment end to pre entry and day 1 of each treatment cycle.
Time Frame
Pre-entry, day 1, treatment end

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte E. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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