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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cavity Cancer
• Intervention / Treatment: Drug: capecitabine; Drug: docetaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1096
      • Wake Forest University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Quality of Life	comparison of treatment end to pre entry and day 1 of each treatment cycle.	Pre-entry, day 1, treatment end

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 19, 2006
• First Submitted That Met QC Criteria: July 19, 2006
• First Posted (Estimate): July 20, 2006

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: recurrent ovarian epithelial cancer; fallopian tube cancer; ovarian serous cystadenocarcinoma; ovarian undifferentiated adenocarcinoma; ovarian clear cell cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian mucinous cystadenocarcinoma; peritoneal cavity cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Peritoneal Diseases; Genital Neoplasms, Female; Adnexal Diseases; Digestive System Neoplasms; Fallopian Tube Diseases; Abdominal Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine
• Other Study ID Numbers: CCCWFU-83203; CCCWFU-BG05-536; AVENTIS-CCCWFU-83203; CDR0000489036; ROCHE-CCCWFU-BG05-536

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No