Fallopian Tube CancerPhase 2NCT00005645
ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
A Phase 2 study testing ILX-295501 in people with Fallopian Tube Cancer and Metastatic Cancer, run by Genzyme, a Sanofi Company at 8 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer
- What is being tested?
- ILX-295501
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- May 1999to not given
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial cancer, including fallopian tube and extraovarian carcinoma Cytological confirmation in the presence of clear clinical and radiological features of disease allowed Refractory to at least two prior chemotherapy regimens for advanced or metastatic disease At least one taxane/platinum containing regimen with or without one topotecan regimen Recurrent or progressive disease while on or within 6 months of last therapy regimen Must have progressed on or within 3 months of receiving topotecan as last therapy regimen Measurable disease outside previously irradiated field OR Objective evidence of disease progression if within previously irradiated field CA 125 at least 35 units/mL No CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) Albumin greater than 2.5 g/dL Renal: Creatinine no greater than ULN Other: No known hypersensitivity to sulfa compounds No known glucose-6-phosphate dehydrogenase deficiency No active or uncontrolled infection No other malignancy within the past 2 years No other severe disease including neurologic or psychiatric disorders that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy, excluding contraceptives or corticosteroids Radiotherapy: See Disease Characteristics Prior radiotherapy to less than 25% bone marrow allowed No prior whole pelvic radiotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 4 weeks since prior investigational agents No other concurrent investigational agents
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Mercy Medical Center, Inc.
Baltimore, Maryland, 21202
Billings Oncology Associates
Billings, Montana, 59101
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
St. Vincents Comprehensive Cancer Center
New York, New York, 10011
Virginia Mason Medical Center
Seattle, Washington, 98111
Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy.
Read the detailed description
OBJECTIVES: I. Determine the objective response in patients with refractory stage III or IV ovarian epithelial cancer treated with ILX-295501. II. Determine the number of patients with at least 50% decrease in CA125 when treated with this regimen. III. Determine the time to tumor progression, overall survival, and toxicity profile in this patient population treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive oral ILX-295501 once weekly for 3 weeks. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months until death.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study.
- Conditions
- Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Being tested
- ILX-295501
- Keywords
- stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, liver metastases, malignant pericardial effusion, malignant pleural effusion, malignant ascites, fallopian tube cancer, primary peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILX-295501Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2004 (estimated)
- Study startMay 1999
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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gayle Cook, RN, Study chair, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005645
- Sponsor's protocol ID
- CDR0000067825
- Other IDs
- ILEX-295501-211, CND-99-039, UCLA-9908032
- Status last verified
- Feb 2001
- First submitted
- 2 May 2000
- Last updated
- 18 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00005645
- Acronym / sponsor ID
- CDR0000067825
- Conditions
- Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Keywords
- stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, liver metastases, malignant pericardial effusion, malignant pleural effusion, malignant ascites, fallopian tube cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 1999
- First posted
- 26 May 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy.
Detailed description
OBJECTIVES: I. Determine the objective response in patients with refractory stage III or IV ovarian epithelial cancer treated with ILX-295501. II. Determine the number of patients with at least 50% decrease in CA125 when treated with this regimen. III. Determine the time to tumor progression, overall survival, and toxicity profile in this patient population treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive oral ILX-295501 once weekly for 3 weeks. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months until death.
PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| ILX-295501 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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RecruitingObservational study
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RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
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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.
Gayle Cook, RN study chair
Genzyme, a Sanofi Company
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ILX-295501 in people with Fallopian Tube Cancer and Metastatic Cancer, run by Genzyme, a Sanofi Company at 8 sites 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: withdrawn, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was withdrawn before enrolling participants, so there are no results.
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 18 Sep 2018.