Fallopian Tube CancerPhase 2NCT00096239
CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
A Phase 2 study testing CP-547,632 in people with Fallopian Tube Cancer and Ovarian Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- CP-547,632
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Feb 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, primary peritoneal serous, or fallopian tube cancer
- Recurrent or persistent disease
- Elevated CA 125, defined as ≥ 40 U/mL on 2 separate consecutive measurements taken ≥ 1 week apart
- No definitive disease OR small-volume disease (≤ 2 cm by spiral or conventional CT scan or clinical exam)
- Asymptomatic disease
PATIENT CHARACTERISTICS:
Age
- 26 and over (age 18 to 25 allowed provided there is closure of the epiphyses on radiography)
Performance status
- ECOG 0-1
Life expectancy
- More than 6 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- No bleeding disorders
- No hemorrhage ≥ grade 2 within the past 12 months
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- ALT and/or AST ≤ 2.5 times ULN
- Albumin ≥ 3.2 g/dL
- PT/PTT ≤ 1.5 times ULN
- INR ≤ 1.5
Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- QTc ≤ 460 msec by ECG
- No unstable angina within the past 6 months
- No decompensated congestive heart failure within the past 6 months
- No myocardial infarction within the past 6 months
- No serious cardiac arrhythmias or conduction abnormalities, including any history of recurrent ventricular arrhythmia, within the past 6 months
- No cardiomyopathy
- No history of syncope associated with arrhythmia
- No uncontrolled hypertension within the past 3 weeks, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg on ≥ 2 of 3 blood pressure readings taken ≥ 5 minutes apart
- No thrombotic cardiovascular events, including transient ischemic attacks, within the past 12 months
Gastrointestinal
- Able to take oral medication
- No malabsorption syndromes
- No active gastrointestinal bleeding (hematemesis, hematochezia, or melena), unrelated to cancer, within the past 3 months
- No requirement for IV alimentation
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active infection
- No uncontrolled diabetes
- No dementia, altered mental status, or uncontrolled psychiatric illness that would preclude giving informed consent or study compliance
- No other serious uncontrolled medical disorder that would preclude study participation
- No other active malignancy within the past 3 years except treated limited stage basal cell or squamous cell skin cancer or carcinoma in situ of the breast or cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior exposure to mouse antibodies
- No prior vascular endothelial growth factor (VEGF) or VEGF-receptor targeted therapy
- No other prior antiangiogenic anticancer therapy, including thalidomide
- No concurrent prophylactic colony-stimulating factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])
- No concurrent immunotherapy
Chemotherapy
- Prior chemotherapy allowed provided patient received only a first-line platinum-based chemotherapy regimen with or without systemic consolidation chemotherapy
- At least 3 weeks since prior chemotherapy and recovered (excluding alopecia)
- No concurrent chemotherapy
Endocrine therapy
- At least 3 weeks since prior hormonal therapy for ovarian cancer and recovered
- Concurrent hormone replacement therapy allowed
- No concurrent chronic oral or IV corticosteroids
- No concurrent hormonal therapy, including tamoxifen
Radiotherapy
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgical procedure
- No prior gastric resection
Other
- More than 3 weeks since prior investigational therapy
- More than 4 weeks since prior major medical interference with the peritoneum or pleura
- More than 3 months since prior treatment for active ulcer disease
- No prior consolidation intraperitoneal therapy using cytotoxic agents for ovarian cancer
- No concurrent antiarrhythmics
- Beta blockers or calcium channel blockers used for other indications allowed
- No concurrent grapefruit juice
- No concurrent therapeutic anticoagulant therapy or chronic daily aspirin > 325 mg/day
- Concurrent low-dose anticoagulants for maintenance of central venous access allowed
- No other concurrent experimental or anticancer therapy for the primary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Phase II Open-Label, Multi-Center Study of CP-547, 632, an Oral Tyrosine Kinase Inhibitor of VEGFR-2, in Subjects With Recurrent or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, or Fallopian Tube Cancer
RATIONALE: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of CP-547,632, in terms of clinical response benefit (CA 125 response [complete response (CR) or partial response (PR)] or stable disease ≥ 16 weeks), in patients with recurrent or persistent small-volume ovarian epithelial, primary peritoneal serous, or fallopian tube cancer.
Secondary
- Determine progression-free survival of patients treated with this drug.
- Determine CA 125 response (CR or PR) rate in patients treated with this drug.
- Determine duration of CA 125 response in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Correlate the steady state plasma concentration of this drug with efficacy and toxicity in these patients.
- Correlate clinical outcome with an angiogenic profile derived from measurement of serum vascular endothelial growth factor, basic fibroblast growth factor, and interleukin-8 in patients treated with this drug.
- Determine changes in the Hospital Anxiety and Depression Scale (HADS) in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral CP-547,632 once daily on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1 year.
- Being tested
- CP-547,632
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer
- 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.
CP-547,632Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startDec 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mark D. Pegram, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096239
- Sponsor's protocol ID
- CDR0000390237
- Other IDs
- UCLA-0311057-01, PFIZER-A3521003
- Status last verified
- Feb 2005
- First submitted
- 9 Nov 2004
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-Label, Multi-Center Study of CP-547, 632, an Oral Tyrosine Kinase Inhibitor of VEGFR-2, in Subjects With Recurrent or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00096239
- Acronym / sponsor ID
- CDR0000390237
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Study completion
- Feb 2005 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: CP-547,632 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well CP-547,632 works in treating patients with recurrent or persistent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of CP-547,632, in terms of clinical response benefit (CA 125 response [complete response (CR) or partial response (PR)] or stable disease ≥ 16 weeks), in patients with recurrent or persistent small-volume ovarian epithelial, primary peritoneal serous, or fallopian tube cancer.
Secondary
- Determine progression-free survival of patients treated with this drug.
- Determine CA 125 response (CR or PR) rate in patients treated with this drug.
- Determine duration of CA 125 response in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Correlate the steady state plasma concentration of this drug with efficacy and toxicity in these patients.
- Correlate clinical outcome with an angiogenic profile derived from measurement of serum vascular endothelial growth factor, basic fibroblast growth factor, and interleukin-8 in patients treated with this drug.
- Determine changes in the Hospital Anxiety and Depression Scale (HADS) in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral CP-547,632 once daily on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CP-547,632 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Mark D. Pegram, MD principal investigator
Jonsson Comprehensive Cancer Center
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 CP-547,632 in people with Fallopian Tube Cancer and Ovarian Cancer, run by Jonsson Comprehensive Cancer Center 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?
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: finished, as of the sponsor's last update on 19 Dec 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Dec 2013.