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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00354601
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 30
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer	Drug: capecitabine; Drug: docetaxel	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• 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: Jan 1, 2006
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Objective Tumor Response [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 [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 [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 [Pre-entry, day 1, treatment end]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

• Study Chair: Brigitte E. Miller, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00354601
• Other Study ID Numbers: CCCWFU-83203; CCCWFU-83203; CCCWFU-BG05-536; AVENTIS-CCCWFU-83203; CDR0000489036; ROCHE-CCCWFU-BG05-536
• First Posted: Jul 20, 2006
• Last Update Posted: Aug 30, 2017
• Last Verified: Mar 1, 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; Docetaxel; Capecitabine

Study Results

Participant Flow

Recruitment Details	Patients enrolled 01/23/2006 to 03/16/2007 at which time the protocol was suspended for lack of funding

Arm/Group Title	Docetaxel and Capecitabine
Arm/Group Description	Docetaxel and Capecitabine therapy per protocol
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Docetaxel and Capecitabine
Arm/Group Description	Docetaxel and Capecitabine therapy per protocol
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.15 (8.84)
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

unable to analyze due to failure to complete treatment or study

Arm/Group Title	Docetaxel and Capecitabine
Arm/Group Description	Docetaxel and Capecitabine therapy per protocol
Measure Participants	0

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

tracked during incomplete treatment period

Arm/Group Title	Docetaxel and Capecitabine
Arm/Group Description	Docetaxel and Capecitabine therapy per protocol
Measure Participants	2
Number [participants]	1 50%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

neither patient completed study

Arm/Group Title	Docetaxel and Capecitabine
Arm/Group Description	Docetaxel and Capecitabine therapy per protocol
Measure Participants	0

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

unable to measure due to failure to complete

Arm/Group Title	Docetaxel and Capecitabine
Arm/Group Description	Docetaxel and Capecitabine therapy per protocol
Measure Participants	0

Adverse Events

Arm/Group Title	Docetaxel and Capecitabine
Arm/Group Description	Docetaxel and Capecitabine therapy per protocol
All Cause Mortality
	Docetaxel and Capecitabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Docetaxel and Capecitabine
	Affected / at Risk (%)	# Events
Total	1/ (NaN)
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	Docetaxel and Capecitabine
	Affected / at Risk (%)	# Events
Total	2/ (NaN)
Gastrointestinal disorders
Diarrhea	2/2 (100%)	2
Taste alteration (dysgeusia)	2/2 (100%)	2
General disorders
Fatigue (asthenia, lethargy, malaise)	2/2 (100%)	2

Limitations/Caveats

Early closure due to discontinuation of funding

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.