Ovarian CancerPhase 2NCT00087087
Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase 2 study testing pemetrexed disodium in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 35 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- pemetrexed disodium
- How many people
- 51 participants
- Where
- 35 sitesUnited States
- Study dates
- Jul 2004to Dec 2006
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial or primary peritoneal cancer
- Recurrent or persistent disease
- Measurable disease
- At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
- Tumors within a previously irradiated field are considered non-target lesions
- Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease
- Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel
- Platinum-resistant or refractory disease
- Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN*
- AST and ALT ≤ 3 times ULN* NOTE: * ≤ 5 times ULN if due to hepatic metastases
Renal
- Creatinine clearance ≥ 45 mL/min
Other
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No neuropathy (sensory or motor) > grade 1
- No active infection requiring antibiotics
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following:
- Monoclonal antibodies
- Cytokines
- Small-molecule inhibitors of signal transduction
- At least 3 weeks since prior biologic or immunologic therapy
- At least 24 hours since prior growth factors
- No concurrent routine colony-stimulating factors
Chemotherapy
- See Disease Characteristics
- Recovered from prior chemotherapy
- No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
- No prior pemetrexed disodium
Endocrine therapy
- At least 1 week since prior hormonal therapy for the malignant tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to > 25% of bone marrow
- At least 2 weeks since prior radiotherapy and recovered
Surgery
- Recovered from prior surgery
Other
- No prior cancer treatment that would preclude study participation
- No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration
- Concurrent low-dose (≤ 325 mg/day) aspirin allowed
- At least 3 weeks since other prior therapy for the malignant tumor
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18105
Hope A Women's Cancer Center
Asheville, North Carolina, 28801
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
CCOP - Dayton
Dayton, Ohio, 45429
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
CCOP - Kalamazoo
Kalamazoo, Michigan, 49008
CCOP - Kansas City
Kansas City, Missouri, 64131
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37901
Women's Cancer Center - Las Vegas
Las Vegas, Nevada, 89102
UMDNJ University Hospital
Newark, New Jersey, 07103
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0037
Williamette Gynecologic Oncology PC
Salem, Oregon, 97301
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802
St. John's Regional Health Center
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
Stony Brook University Cancer Center
Stony Brook, New York, 11794-8174
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, 74104
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Being tested
- pemetrexed disodium
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed disodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor activity
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startJul 2004
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- David S. Miller, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087087
- Sponsor's protocol ID
- GOG-0126Q
- Other IDs
- LILLY-H3E-US-JMGP, CDR0000372919
- Status last verified
- Feb 2014
- First submitted
- 8 Jul 2004
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT00087087
- Acronym / sponsor ID
- GOG-0126Q
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), Eli Lilly and Company
- Study start
- Jul 2004
- Primary completion
- Dec 2006 (actual)
- First posted
- 12 Jul 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, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| pemetrexed disodium | Drug | – |
Primary outcome
Antitumor activity
Toxicity
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 14 Feb 2014.
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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 S. Miller, MD study chair
Simmons Cancer Center
35 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 pemetrexed disodium in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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 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?
Antitumor activity. 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?
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 14 Feb 2014.