Cervical CancerPhase 2NCT00002562
Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer
A Phase 2 study testing paclitaxel in people with Cervical Cancer and Vaginal Cancer, run by Gynecologic Oncology Group at 50 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 paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer, Vaginal Cancer
- What is being tested?
- paclitaxel
- How many people
- 25 participants
- Where
- 50 sitesUnited States
- Study dates
- Mar 1994to Aug 2004
- 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 advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina or cervix Documented disease progression after local therapy required Disease must be considered incurable Bidimensionally measurable disease required by physical examination or medical imaging
PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000 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 more than 2.0 mg/dL Other: Not eligible for a higher priority GOG protocol No significant infection No prior or concomitant second malignancy except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: At least 3 weeks since therapy directed at malignancy Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen (either single or combination cytotoxic drug therapy) No prior paclitaxel Recovery from prior chemotherapy required Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent disease except a low dose, single fraction used to abrogate menorrhagia Recovery from prior radiotherapy required Surgery: Recovery from prior surgery required
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 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
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
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
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
Women's Cancer Center
Palo Alto, California, 94304
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Pennsylvania Hospital
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, 11790-9832
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: EVALUATION OF PACLITAXEL (TAXOL) IN PERSISTENT OR RECURRENT NON-SQUAMOUS CELL CARCINOMA OF THE CERVIX AND VAGINA
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 paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.
Read the detailed description
OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. II. Determine the frequency and severity of observed adverse effects on this study.
OUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.
PROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.
- Conditions
- Cervical Cancer, Vaginal Cancer
- Being tested
- paclitaxel
- Keywords
- recurrent cervical cancer, recurrent vaginal cancer, vaginal clear cell adenocarcinoma, cervical adenocarcinoma
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2004 (estimated)
- Study startMar 1994
- Study completionAug 2004
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 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
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- John P. Curtin, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002562
- Sponsor's protocol ID
- CDR0000063506
- Other IDs
- GOG-128B
- Status last verified
- Dec 2005
- First submitted
- 1 Nov 1999
- Last updated
- 20 Jun 2013
- Results posted
- No
Publications
Curtin JP, Blessing JA, Webster KD, Rose PG, Mayer AR, Fowler WC Jr, Malfetano JH, Alvarez RD. Paclitaxel, an active agent in nonsquamous carcinomas of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2001 Mar 1;19(5):1275-8. doi: 10.1200/JCO.2001.19.5.1275.
PubMed 11230468
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF PACLITAXEL (TAXOL) IN PERSISTENT OR RECURRENT NON-SQUAMOUS CELL CARCINOMA OF THE CERVIX AND VAGINA
- ClinicalTrials.gov ID
- NCT00002562
- Acronym / sponsor ID
- CDR0000063506
- Conditions
- Cervical Cancer, Vaginal Cancer
- Keywords
- recurrent cervical cancer, recurrent vaginal cancer, vaginal clear cell adenocarcinoma, cervical adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1994
- Study completion
- Aug 2004 (actual)
- First posted
- 10 Aug 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 paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.
Detailed description
OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. II. Determine the frequency and severity of observed adverse effects on this study.
OUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.
PROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.
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 |
|---|---|---|
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Jun 2013.
- Results publication: PubMed 11230468Curtin JP, Blessing JA, Webster KD, Rose PG, Mayer AR, Fowler WC Jr, Malfetano JH, Alvarez RD. Paclitaxel, an active agent in nonsquamous carcinomas of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2001 Mar 1;19(5):1275-8. doi: 10.1200/JCO.2001.19.5.1275.
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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.
John P. Curtin, MD study chair
Memorial Sloan Kettering Cancer Center
50 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 paclitaxel in people with Cervical Cancer and Vaginal Cancer, run by Gynecologic Oncology Group at 50 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 20 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 50 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002562, 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 20 Jun 2013.