Ovarian NeoplasmsPhase 2NCT01313078
Phase II Study of Clinical Activity of Pegaspargase in Women With Relapsed or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
A Phase 2 study testing Pegylated L-Asparaginase in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The best treatment for ovarian and related female reproductive tract cancers is not yet known for patients whose disease has not responded to or has recurred after standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Primary Peritoneal Neoplasms
- What is being tested?
- Pegylated L-Asparaginase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients 18 years and older with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is persistent, relapsed or refractory to prior standard platinum and taxane-based therapy will be eligible. Tumor histology must be reviewed and confirmed by the National Cancer Institute (NCI) Laboratory of Pathology. Recurrent ovarian cancer is not a curable tumor. Patients who are platinum-sensitive and who, upon detailed informed consent, wish to consider this experimental regimen, will be considered.
- All patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A sentinel lesion adequate for core biopsy through percutaneous route is ideal but not mandatory. Patients with a malignant pleural effusion or malignant ascites will be allowed to undergo a paracentesis or thoracentesis rather than core needle biopsy if the procedure may be performed safely.
- Patients must have a performance status of Eastern Cooperative Oncology Group (ECOG) = 0, 1, 2
- Patients must have adequate end organ function:
- Absolute neutrophil count (ANC) greater than or equal to 1500/ mm^3
- Platelets greater than or equal to 100,000/ mm^3
Show all 17Show fewer
- Serum creatinine less than or equal to 1.5 mg/dL, or if low, creatinine clearance greater than or equal to 60 mL/min
- Total bilirubin less than or equal to 1.5 times the ULN (upper limit of normal) unless a history of Gilbert's disease.
- Lipase and amylase less than or equal to 1.5 times the ULN
- Transaminases (aspartate aminotransferase (AST), alanine aminotransferase (ALT)) less than or equal to 2.5 times the ULN
- Fibrinogen greater than or equal to 0.75 times the LLN
- Prothrombin time (PT), partial thromboplastin time (PTT), and International Normalized Ratio (INR) less than or equal to 1.5 times the ULN. Coagulation parameters must be drawn peripherally.
- Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, alternative therapy, investigational agents, or a major surgical procedure). Patients must be 6 weeks from carboplatin- or mitomycin C-containing therapy. Exceptions: Raloxifene will be allowed for bone health and bisphosphonate therapy will be allowed for the rare situation of bone metastasis.
- There is no limit to the number of prior regimens patients may have received for the treatment of ovarian cancer.
- Patients must have recovered from any toxicity related to prior cancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) grade 1, except for stable peripheral neuropathy, which must have recovered to grade 2 or better, and grade 2 total white blood cell count when ANC is greater than or equal to 1500 (alopecia and hypertension exempted).
- Women of childbearing potential must agree to use adequate barrier contraception (interaction with oral contraceptives is unknown) prior to study entry, during therapy and for 3 months after completion of therapy and must have a negative pregnancy test.
- Patients must be able to give written informed consent.
Who cannot join
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it unsafe for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Evidence of central nervous system (CNS) involvement. Patients with abnormal clinical exam or history will require a head computed tomography (CT) or magnetic resonance imaging (MRI).
- History of clinically symptomatic pancreatitis within the six months prior to enrollment.
- History of prior exposure to any formulation of L-asparaginase.
- Patients with a history of deep venous thrombosis or pulmonary embolism within the past 3 months, or pulmonary embolism within the past 6 months, history of recurrent clot or pulmonary embolism (PE), or those patients requiring ongoing full dose anticoagulation will be ineligible. Line prophylaxis with 1 mg warfarin daily will be allowed.
- Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics.
Show all 9Show fewer
- Women who are pregnant and women actively breast-feeding will be excluded.
- Previous or current malignancies within the last 5 years, with the exception of cervical carcinoma in situ curatively treated, ductal or lobular carcinoma in situ curatively treated and without ongoing therapeutic intervention, and nonmelanomatous skin cancers curatively treated.
- No concomitant use of complementary or alternative medication or other agents (investigational or anti-cancer agents) will be allowed without approval of a principal investigator (PI) or associate investigator (AI). Every effort will be made to maximize patient safety and minimize changes in chronic medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- The best treatment for ovarian and related female reproductive tract cancers is not yet known for patients whose disease has not responded to or has recurred after standard treatment. The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works differently from standard chemotherapy, has been approved to treat leukemia and has been given to a small number of patient with ovarian and other types of cancer. Because pegaspargase may reduce the development of cancer cells and blood vessel cells that contribute to cancer growth and ability to spread, treatment with pegaspargase could shrink ovarian cancer tumors and help ovarian cancer patients live longer and with fewer symptoms from their disease.
Read more
Objectives:
- To evaluate the safety and effectiveness of pegaspargase in patients with recurrent or refractory ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer.
Eligibility:
- Women at least 18 years of age who have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to at least one operation, chemotherapy, and/or radiotherapy.
Design:
- Before the start of the study, participants will be screened with a medical history, blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as directed by the study doctors.
- Participants will receive an infusion of pegaspargase on Day 1 and Day 15 of each 28-day cycle.
- Participants will have dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at the start of the study, before beginning pegaspargase, and again 6 weeks into the treatment. This test will determine if pegaspargase is affecting blood flow to the cancer site.
- Participants will have a computed tomography scan or other imaging every other cycle (approximately every 8 weeks) to determine whether the therapy is affecting the cancer site.
- The treatment will be repeated as long as the participant tolerates the medication and his or her cancer is either steady or improving.
Read the detailed description
Background:
- The bacterial enzyme L-asparaginase (L-ASP) catalyzes hydrolysis of asparagine to aspartate and is used to treat acute lymphoblastic leukemia (ALL).Studies demonstrated in vitro cytotoxic activity against solid tumor types including ovarian cancer.
- Our laboratory demonstrated L-ASP inhibits vascular remodeling and modulates heterotypic adhesion interactions between ovarian cancer cells and endothelial cells. Results indicate L-ASP has the ability to modify the local tumor microenvironment.
- Epithelial ovarian cancer requires neovascularization for growth and metastasis. Anti-angiogenesis agents show promise in treatment of recurrent disease.
- The pegylated form of L-ASP, pegaspargase, (Sigma Tau ONCASPAR (Trademark)) is shown to deplete serum levels of asparagine and is approved for ALL. ONCASPAR is in clinical trial with gemcitabine for pancreatic cancer and other solid tumors.
- Recommended dose of pegaspargase in ALL is 2,500 IU/m^2 every two weeks intramuscular (IM)/intravenous (IV). IM dosing of 2,000 IU/m^2 every two weeks has been studied in a phase I protocol with various solid tumors.
- Demonstration of safety and anti-angiogenic activity will lead to combination studies.
Primary Objectives:
- To preliminarily evaluate the anti-tumor activity of pegaspargase, 2,000 IU/ m^2 every two weeks intravenous (IV) (or intramuscular (IM)) and explore associations with toxicity and clinical outcome.
- To evaluate the safety of pegaspargase in patients with recurrent or refractory ovarian, fallopian tube, and/or primary peritoneal cancer.
Secondary Objectives:
- To explore changes in circulating angiogenic cytokines after treatment with pegaspargase.
- To measure apoptosis and proliferation in tumor (or malignant effusion) by protein array before and during therapy.
- To evaluate changes in tumor vascularity using dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI).
Eligibility:
- Women with epithelial ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer that is persistent, relapsed and/or refractory to prior therapy.
- There is no limit to number of prior treatment regimens. Patients may not have previously received L-ASP.
- Women must have disease amenable to biopsy or malignant effusions (pleural effusion or ascites) that may be serially tapped.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2.
- Evidence of adequate end organ function and normal coagulation parameters (prothrombin time (PT), activated partial thromboplastin time (aPTT)).
Design:
- Women will receive 2,000 IU/m^2 of pegaspargase intravenously every two weeks in 28-day cycles until disease progression, excessive toxicity, or withdrawal from study.
- Biopsy of tumor and dynamic contrast-enhanced-magnetic resonance imaging (MRI) will be performed prior to starting pegaspargase (mandatory) and after 6 weeks of treatment (optional).
- Clinical outcome will be measured and correlated with biological endpoints.
- Research blood samples will be taken to assess changes in serum vascular endothelial growth factor (VEGF), interleukin-6 (IL6), and interleukin-8 (IL8).
- Blood will be collected to evaluate circulating endothelial cells.
- Patients will be seen in clinic every 4 weeks and outcome measured every other cycle.
- Being tested
- Pegylated L-Asparaginase
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Relapsed or Refractory, Pegaspargase, Pegylated L-Asparaginase
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated L-AsparaginaseDrug
Also called Oncaspar
Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pegaspargase in women with cancer | Experimental | Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks Receives: Drug: Pegylated L-Asparaginase |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Progression Free Survival
Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as >20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.
Measured: 6 months
Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Measured: 11 months, 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elise C Kohn, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313078
- Sponsor's protocol ID
- 100028
- Other IDs
- 10-C-0028
- Status last verified
- Aug 2012
- First submitted
- 9 Mar 2011
- Last updated
- 9 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
PubMed 18287387Liotta LA, Kohn EC. The microenvironment of the tumour-host interface. Nature. 2001 May 17;411(6835):375-9. doi: 10.1038/35077241.
PubMed 11357145Alvarez AA, Krigman HR, Whitaker RS, Dodge RK, Rodriguez GC. The prognostic significance of angiogenesis in epithelial ovarian carcinoma. Clin Cancer Res. 1999 Mar;5(3):587-91.
PubMed 10100710
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Clinical Activity of Pegaspargase in Women With Relapsed or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01313078
- Acronym / sponsor ID
- 100028
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Relapsed or Refractory, Pegaspargase, Pegylated L-Asparaginase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 12 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- The best treatment for ovarian and related female reproductive tract cancers is not yet known for patients whose disease has not responded to or has recurred after standard treatment. The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works differently from standard chemotherapy, has been approved to treat leukemia and has been given to a small number of patient with ovarian and other types of cancer. Because pegaspargase may reduce the development of cancer cells and blood vessel cells that contribute to cancer growth and ability to spread, treatment with pegaspargase could shrink ovarian cancer tumors and help ovarian cancer patients live longer and with fewer symptoms from their disease.
Objectives:
- To evaluate the safety and effectiveness of pegaspargase in patients with recurrent or refractory ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer.
Eligibility:
- Women at least 18 years of age who have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to at least one operation, chemotherapy, and/or radiotherapy.
Design:
- Before the start of the study, participants will be screened with a medical history, blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as directed by the study doctors.
- Participants will receive an infusion of pegaspargase on Day 1 and Day 15 of each 28-day cycle.
- Participants will have dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at the start of the study, before beginning pegaspargase, and again 6 weeks into the treatment. This test will determine if pegaspargase is affecting blood flow to the cancer site.
- Participants will have a computed tomography scan or other imaging every other cycle (approximately every 8 weeks) to determine whether the therapy is affecting the cancer site.
- The treatment will be repeated as long as the participant tolerates the medication and his or her cancer is either steady or improving.
Detailed description
Background:
- The bacterial enzyme L-asparaginase (L-ASP) catalyzes hydrolysis of asparagine to aspartate and is used to treat acute lymphoblastic leukemia (ALL).Studies demonstrated in vitro cytotoxic activity against solid tumor types including ovarian cancer.
- Our laboratory demonstrated L-ASP inhibits vascular remodeling and modulates heterotypic adhesion interactions between ovarian cancer cells and endothelial cells. Results indicate L-ASP has the ability to modify the local tumor microenvironment.
- Epithelial ovarian cancer requires neovascularization for growth and metastasis. Anti-angiogenesis agents show promise in treatment of recurrent disease.
- The pegylated form of L-ASP, pegaspargase, (Sigma Tau ONCASPAR (Trademark)) is shown to deplete serum levels of asparagine and is approved for ALL. ONCASPAR is in clinical trial with gemcitabine for pancreatic cancer and other solid tumors.
- Recommended dose of pegaspargase in ALL is 2,500 IU/m^2 every two weeks intramuscular (IM)/intravenous (IV). IM dosing of 2,000 IU/m^2 every two weeks has been studied in a phase I protocol with various solid tumors.
- Demonstration of safety and anti-angiogenic activity will lead to combination studies.
Primary Objectives:
- To preliminarily evaluate the anti-tumor activity of pegaspargase, 2,000 IU/ m^2 every two weeks intravenous (IV) (or intramuscular (IM)) and explore associations with toxicity and clinical outcome.
- To evaluate the safety of pegaspargase in patients with recurrent or refractory ovarian, fallopian tube, and/or primary peritoneal cancer.
Secondary Objectives:
- To explore changes in circulating angiogenic cytokines after treatment with pegaspargase.
- To measure apoptosis and proliferation in tumor (or malignant effusion) by protein array before and during therapy.
- To evaluate changes in tumor vascularity using dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI).
Eligibility:
- Women with epithelial ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer that is persistent, relapsed and/or refractory to prior therapy.
- There is no limit to number of prior treatment regimens. Patients may not have previously received L-ASP.
- Women must have disease amenable to biopsy or malignant effusions (pleural effusion or ascites) that may be serially tapped.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2.
- Evidence of adequate end organ function and normal coagulation parameters (prothrombin time (PT), activated partial thromboplastin time (aPTT)).
Design:
- Women will receive 2,000 IU/m^2 of pegaspargase intravenously every two weeks in 28-day cycles until disease progression, excessive toxicity, or withdrawal from study.
- Biopsy of tumor and dynamic contrast-enhanced-magnetic resonance imaging (MRI) will be performed prior to starting pegaspargase (mandatory) and after 6 weeks of treatment (optional).
- Clinical outcome will be measured and correlated with biological endpoints.
- Research blood samples will be taken to assess changes in serum vascular endothelial growth factor (VEGF), interleukin-6 (IL6), and interleukin-8 (IL8).
- Blood will be collected to evaluate circulating endothelial cells.
- Patients will be seen in clinic every 4 weeks and outcome measured every other cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegaspargase in women with cancer | Experimental | Drug: Pegylated L-AsparaginasePegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- All patients 18 years and older with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is persistent, relapsed or refractory to prior standard platinum and taxane-based therapy will be eligible. Tumor histology must be reviewed and confirmed by the National Cancer Institute (NCI) Laboratory of Pathology. Recurrent ovarian cancer is not a curable tumor. Patients who are platinum-sensitive and who, upon detailed informed consent, wish to consider this experimental regimen, will be considered.
- All patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A sentinel lesion adequate for core biopsy through percutaneous route is ideal but not mandatory. Patients with a malignant pleural effusion or malignant ascites will be allowed to undergo a paracentesis or thoracentesis rather than core needle biopsy if the procedure may be performed safely.
- Patients must have a performance status of Eastern Cooperative Oncology Group (ECOG) = 0, 1, 2
- Patients must have adequate end organ function:
- Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, alternative therapy, investigational agents, or a major surgical procedure). Patients must be 6 weeks from carboplatin- or mitomycin C-containing therapy. Exceptions: Raloxifene will be allowed for bone health and bisphosphonate therapy will be allowed for the rare situation of bone metastasis.
Key exclusion criteria (9 listed)
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it unsafe for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Evidence of central nervous system (CNS) involvement. Patients with abnormal clinical exam or history will require a head computed tomography (CT) or magnetic resonance imaging (MRI).
- History of clinically symptomatic pancreatitis within the six months prior to enrollment.
- History of prior exposure to any formulation of L-asparaginase.
- Patients with a history of deep venous thrombosis or pulmonary embolism within the past 3 months, or pulmonary embolism within the past 6 months, history of recurrent clot or pulmonary embolism (PE), or those patients requiring ongoing full dose anticoagulation will be ineligible. Line prophylaxis with 1 mg warfarin daily will be allowed.
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 |
|---|---|---|
| Pegylated L-AsparaginaseAlso: OncasparPegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks | Drug | Pegaspargase in women with cancer |
Primary outcome
6 Month Progression Free Survival
Time frame: 6 months
Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as >20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.
Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.
Time frame: 11 months, 25 days
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18287387Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
- Background: PubMed 11357145Liotta LA, Kohn EC. The microenvironment of the tumour-host interface. Nature. 2001 May 17;411(6835):375-9. doi: 10.1038/35077241.
- Background: PubMed 10100710Alvarez AA, Krigman HR, Whitaker RS, Dodge RK, Rodriguez GC. The prognostic significance of angiogenesis in epithelial ovarian carcinoma. Clin Cancer Res. 1999 Mar;5(3):587-91.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Elise C Kohn, M.D. principal investigator
National Cancer Institute (NCI)
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 Pegylated L-Asparaginase in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by National Cancer Institute (NCI) 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 17 inclusion and 9 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: finished, as of the sponsor's last update on 9 Oct 2015. 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 12 Sep 2012). 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?
6 Month Progression Free Survival (time frame: 6 months). The study lists 2 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 NCT01313078, which also lists 3 linked publications.
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 9 Oct 2015.