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Cervical CancerPhase 2NCT00087126

Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer

A Phase 2 study testing topotecan hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, 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 topotecan works in treating women with persistent or recurrent cervical cancer. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
topotecan hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
27 sitesUnited States
Study dates
Feb 2005to Jan 2010
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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoma of the cervix
  • Squamous cell or nonsquamous cell
  • Persistent or recurrent disease
  • Documented disease progression
  • Measurable disease
  • At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days after completion of prior radiotherapy
  • Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or nonsquamous cell carcinoma of the cervix
  • Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Sensory or motor neuropathy ≤ grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No other malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, 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 agents for cervical cancer
  • No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim
  • No concurrent prophylactic thrombopoietic agents

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
  • No prior topotecan

Endocrine therapy

  • At least 1 week since prior hormonal therapy for cervical cancer
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapy for cervical cancer
  • No prior cancer therapy that would preclude study participation

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Kaiser Permanente Medical Center - Los Angeles

    Los Angeles, California, 90027

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Olive View - UCLA Medical Center Foundation

    Sylmar, California, 91342

  • Cancer Care Associates - Midtown Tulsa

    Tulsa, Oklahoma, 74104

Other trials in United States

About this study

Official title: A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix

RATIONALE: Drugs used in chemotherapy, such as topotecan, 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 topotecan works in treating women with persistent or recurrent cervical cancer.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix 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 topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patient are followed for every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.

Conditions
Cervical Cancer
Being tested
topotecan hydrochloride
Keywords
recurrent cervical cancer, cervical squamous cell carcinoma
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topotecan hydrochlorideDrug

Study groups in NCT00087126
Study groupRoleWhat they receive
TopotecanExperimentalTopotecan weekly
Receives: Drug: topotecan hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0

    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

    Measured: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.

  2. Number of Participants With Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

    All participants assessed by CTCAE v3 (Common Terminology Criteria for Adverse Events version 3.0) including grade 0 (the number of participants not affected by the Adverse Event).

    Measured: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startFeb 2005
  3. Primary completionJan 2010

Resources

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087126
Sponsor's protocol ID
GOG-0127U
Other IDs
GOG-0127U, CDR0000372930
Status last verified
May 2015
First submitted
8 Jul 2004
Last updated
8 Jan 2019
Data monitoring committee
Yes

Publications

  • Fiorica JV, Blessing JA, Puneky LV, Secord AA, Hoffman JS, Yamada SD, Buekers TE, Bell J, Schilder JM; Gynecologic Oncology Group. A Phase II evaluation of weekly topotecan as a single agent second line therapy in persistent or recurrent carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2009 Nov;115(2):285-9. doi: 10.1016/j.ygyno.2009.07.024. Epub 2009 Sep 2.

    PubMed 19726073

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing topotecan hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group at 27 sites 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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?

Yes. Results are posted in the registry (first posted 8 Jan 2019). 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?

Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 (time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.). 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 NCT00087126, 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 8 Jan 2019.

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