Cervical CancerPhase 2NCT00002478
Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer
A Phase 2 study testing etoposide in people with Cervical Cancer and Ovarian Cancer, run by Gynecologic Oncology Group at 47 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 etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer, Ovarian Cancer
- What is being tested?
- etoposide
- How many people
- Not given
- Where
- 47 sitesUnited States
- Study dates
- Jun 1993to Oct 2003
- 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 recurrent or metastatic ovarian epithelial or cervical cancer Tissue not accessible for biopsy Refractory to curative therapy or established treatments and ineligible for higher priority GOG protocols Measurable disease required, as follows: Lesion measurable by physical exam Lesion bidimensionally measurable on sonogram or imaging Ascites/pleural effusion not measurable
PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelets at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: Body surface area at least 1 square meter No requirement for intravenous hydration or nutritional support No significant infection No second malignancy other than nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since anticancer therapy Chemotherapy: No more than 1 prior chemotherapy trial No prior etoposide At least 3 weeks since chemotherapy and recovered Endocrine therapy: At least 3 weeks since anticancer therapy Radiotherapy: At least 3 weeks since radiotherapy Surgery: At least 3 weeks since surgery and recovered
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Cancer Center of Albany Medical Center
Albany, New York, 12208
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
University of Colorado Cancer Center
Denver, Colorado, 80262
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
Chao Family Comprehensive Cancer Center
Orange, California, 92868
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Rochester Cancer Center
Rochester, New York, 14642
University of Washington Medical Center
Seattle, Washington, 98195-6043
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305-5408
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
Tacoma General Hospital
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 20007
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical 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 etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.
Read the detailed description
OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16.
OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15 patients will be entered. The estimated duration of the study is 8 months.
- Conditions
- Cervical Cancer, Ovarian Cancer
- Being tested
- etoposide
- Keywords
- recurrent cervical cancer, recurrent ovarian epithelial cancer
- Medical subject headings
- Uterine Cervical 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.
etoposideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startJun 1993
- Primary completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical 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
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Peter G. Rose, MD, Study chair, University Hospitals Seidman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002478
- Sponsor's protocol ID
- CDR0000077078
- Other IDs
- GOG-26LL
- Status last verified
- Nov 2000
- First submitted
- 1 Nov 1999
- Last updated
- 10 Jun 2013
- Results posted
- No
Publications
Rose PG, Blessing JA, Buller RE, Mannel RS, Webster KD. Prolonged oral etoposide in recurrent or advanced non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 May;89(2):267-70. doi: 10.1016/s0090-8258(03)00079-9.
PubMed 12713990Rose PG, Blessing JA, Mayer AR, Homesley HD. Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 1998 Feb;16(2):405-10. doi: 10.1200/JCO.1998.16.2.405.
PubMed 9469322Kudelka A, ed.: A phase II study of prolonged oral VP-16 in women with refractoy epithelial ovarian carcinoma. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-888, 276, 1994.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer
- ClinicalTrials.gov ID
- NCT00002478
- Acronym / sponsor ID
- CDR0000077078
- Conditions
- Cervical Cancer, Ovarian Cancer
- Keywords
- recurrent cervical cancer, recurrent ovarian epithelial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 1993
- Primary completion
- Oct 2003 (actual)
- First posted
- 9 Jun 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 etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.
Detailed description
OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16.
OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15 patients will be entered. The estimated duration of the study is 8 months.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| etoposide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Results publication: PubMed 12713990Rose PG, Blessing JA, Buller RE, Mannel RS, Webster KD. Prolonged oral etoposide in recurrent or advanced non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 May;89(2):267-70. doi: 10.1016/s0090-8258(03)00079-9.
- Results publication: PubMed 9469322Rose PG, Blessing JA, Mayer AR, Homesley HD. Prolonged oral etoposide as second-line therapy for platinum-resistant and platinum-sensitive ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 1998 Feb;16(2):405-10. doi: 10.1200/JCO.1998.16.2.405.
- Results publicationKudelka A, ed.: A phase II study of prolonged oral VP-16 in women with refractoy epithelial ovarian carcinoma. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-888, 276, 1994.
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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.
Peter G. Rose, MD study chair
University Hospitals Seidman Cancer Center
47 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 etoposide in people with Cervical Cancer and Ovarian Cancer, run by Gynecologic Oncology Group at 47 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: stopped early, as of the sponsor's last update on 10 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 47 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 stopped early. Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT00002478, 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 10 Jun 2013.