Fallopian Tube CancerPhase 2NCT00022347
TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
A Phase 2 study testing canfosfamide hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 TLK286 in treating patients who have advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. 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?
- canfosfamide hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2001to Dec 2009
- 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 or cytologically confirmed advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer Serous papillary Endometrioid Mucinous Clear cell Poorly differentiated adenocarcinomas Mixture of any of the above histologies No sarcomatous, stromal, or germ cell elements Measurable disease by radiological imaging with progression in the past 3 months or no response to prior therapy The following are not considered measurable: Pleural effusions Ascites Osseous metastases CA-125 tumor markers Lesions in previously irradiated areas Platinum resistant or refractory Less than 6 month treatment-free interval after platinum-containing regimen OR Progression during platinum-based therapy No leptomeningeal or carcinomatous meningitis Known CNS metastases allowed if patient is previously treated, neurologically stable, has no evidence of active disease by CT or MRI, and has no requirement for therapy with oral or IV steroids or anticonvulsants
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 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 2.5 mg/dL ALT and AST no greater than 3.0 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No gross hematuria Cardiovascular: No uncontrolled cardiac arrhythmia No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No unstable medical conditions No severe concurrent disease or infection that would preclude study No intestinal obstruction interfering with nutrition No psychiatric disorders that would preclude study No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered At least 2 weeks since prior prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) No concurrent immunotherapy No concurrent biological response modifiers Chemotherapy: See Disease Characteristics At least 1 but no more than 3 prior chemotherapy regimens (platinum-containing regimens count as 1 regimen) At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy or radiopharmaceuticals and recovered No prior radiotherapy to whole pelvis No concurrent radiotherapy including palliative radiotherapy (except local radiotherapy for pain or solitary brain metastasis if not progressing systemically) Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 30 days since prior investigational drugs No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial 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 TLK286 in treating patients who have advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES: I. Determine the objective response rate and disease stabilization rate in patients with platinum-resistant advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer treated with TLK286. II. Determine the safety of this regimen in these patients. III. Determine the duration of objective response, time to tumor progression, and overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 12 months.
- Being tested
- canfosfamide hydrochloride
- Keywords
- stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, fallopian tube cancer, primary peritoneal cavity 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.
canfosfamide hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Safety
Duration of objective response
Time to tumor progression
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2004 (estimated)
- Study startMay 2001
- Primary completionApr 2004
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David R. Spriggs, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022347
- Sponsor's protocol ID
- TLK-286.2003
- Other IDs
- MSKCC-01059, CDR0000068807, NCI-G01-1998
- Status last verified
- Dec 2009
- First submitted
- 10 Aug 2001
- Last updated
- 26 Jun 2013
- Results posted
- No
Publications
Kavanagh JJ, Gershenson DM, Choi H, Lewis L, Patel K, Brown GL, Garcia A, Spriggs DR. Multi-institutional phase 2 study of TLK286 (TELCYTA, a glutathione S-transferase P1-1 activated glutathione analog prodrug) in patients with platinum and paclitaxel refractory or resistant ovarian cancer. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):593-600. doi: 10.1111/j.1525-1438.2005.00114.x.
PubMed 16014111
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of TLK 286 in Platinum Resistant Advanced Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00022347
- Acronym / sponsor ID
- TLK-286.2003
- Keywords
- stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Jan 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 TLK286 in treating patients who have advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed description
OBJECTIVES: I. Determine the objective response rate and disease stabilization rate in patients with platinum-resistant advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer treated with TLK286. II. Determine the safety of this regimen in these patients. III. Determine the duration of objective response, time to tumor progression, and overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 12 months.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| canfosfamide hydrochloride | Drug | – |
Primary outcome
Objective response rate
Safety
Duration of objective response
Time to tumor progression
Overall survival
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 26 Jun 2013.
- Results publication: PubMed 16014111Kavanagh JJ, Gershenson DM, Choi H, Lewis L, Patel K, Brown GL, Garcia A, Spriggs DR. Multi-institutional phase 2 study of TLK286 (TELCYTA, a glutathione S-transferase P1-1 activated glutathione analog prodrug) in patients with platinum and paclitaxel refractory or resistant ovarian cancer. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):593-600. doi: 10.1111/j.1525-1438.2005.00114.x.
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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.
David R. Spriggs, MD study chair
Memorial Sloan Kettering 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 canfosfamide hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by Memorial Sloan Kettering 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 26 Jun 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.
What does the primary outcome measure?
Objective response rate. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00022347, which also lists 1 linked publication.
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 26 Jun 2013.