Fallopian Tube CancerPhase 2NCT00354601
Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
A Phase 2 study testing capecitabine and docetaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- What is being tested?
- capecitabine and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 45Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
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
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.
Read the 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.
- Being tested
- capecitabine, docetaxel
- 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
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
oral capecitabine twice daily on days 1-21
docetaxelDrug
docetaxel IV over 30 minutes on days 1, 8, and 15
| Study group | Role | What they receive |
|---|---|---|
| Weekly Docetaxel and Capecitabine | Experimental | Weekly Docetaxel and Capecitabine Receives: Drug: capecitabine; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
Measured: 8 weeks
Secondary outcomes (3)
Time to Progression
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
Measured: 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.
Measured: 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.
Measured: Pre-entry, day 1, treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionJul 2008
Why it stopped: funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brigitte E. Miller, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354601
- Sponsor's protocol ID
- CCCWFU-83203
- Other IDs
- CCCWFU-83203, CCCWFU-BG05-536, AVENTIS-CCCWFU-83203, CDR0000489036, ROCHE-CCCWFU-BG05-536
- Status last verified
- Mar 2017
- First submitted
- 19 Jul 2006
- Last updated
- 30 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00354601
- Acronym / sponsor ID
- CCCWFU-83203
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding withdrawn
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Posted 18 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weekly Docetaxel and Capecitabine | Experimental | Drug: capecitabine, Drug: docetaxelWeekly Docetaxel and Capecitabine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Diagnosis of 1 of the following:
- 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:
- Measurable disease by physical exam, chest x-ray, CT scan, or MRI
- No brain metastases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabineoral capecitabine twice daily on days 1-21 | Drug | Weekly Docetaxel and Capecitabine |
| docetaxeldocetaxel IV over 30 minutes on days 1, 8, and 15 | Drug | Weekly Docetaxel and Capecitabine |
Primary outcome
Objective Tumor Response
Time frame: 8 weeks
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
3 secondary outcomes
Time to Progression
Time frame: Evaluated every 8 weeks during treatment
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)
Quality of Life
Time frame: Pre-entry, day 1, treatment end
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte E. Miller, MD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine and docetaxel in people with Fallopian Tube Cancer and Ovarian Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Tumor Response (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.