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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00354601
• Other study ID #: CCCWFU-83203
• Secondary ID: CCCWFU-83203CCCW
• Status: Terminated
• Phase: Phase 2
• First received: July 19, 2006
• Last updated: September 29, 2015
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2012
• Source: Comprehensive Cancer Center of Wake Forest University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• capecitabine
oral capecitabine twice daily on days 1-21
• docetaxel
docetaxel IV over 30 minutes on days 1, 8, and 15

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Comprehensive Cancer Center of Wake Forest University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Tumor Response	The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines	8 weeks	No
Secondary	Time to Progression	Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter	Evaluated every 8 weeks during treatment	No
Secondary	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.	Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)	Yes
Secondary	Quality of Life	comparison of treatment end to pre entry and day 1 of each treatment cycle.	Pre-entry, day 1, treatment end	No