Uterine Cervical CancerPhase 1/2NCT00184093

Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma

A Phase 1/2 study testing Gemcitabine in people with Uterine Cervical Cancer, run by University of Southern California at 1 site 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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Uterine Cervical Cancer
What is being tested?: Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Jun 1999to May 2009
Phase: Phase 1/2
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

Patients with histologically confirmed bulky stage Ib or stage IIa cervical cancer. Bulky stage Ib disease is defined as tumor mass greater than 4 cms in diameter.
Cervical lesion which is measurable by physical examination.
No prior therapy for invasive cervical cancer.
GOG performance status 0-2
Signed informed consent
Patients must have adequate:

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Bone marrow function: absolute granulocyte count > or = to 1500, platelet count > 100,000.
Renal function: creatinine < or = to 1.8 mg/dl
Hepatic function: bilirubin < or = to 1.5 x normal, SGOT and alkaline phosphatase < or = to 3 x normal

Who cannot join

Patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years.
Pregnant or lactating women. Women of reproductive age may not participate unless they have agreed to use an effective method of birth control.
Patients with uncontrolled infection.
Patients who are HIV positive
Patients with psychiatric or social conditions that would interfere with consent or follow-up.
Patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study

The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.

Conditions: Uterine Cervical Cancer
Being tested: Gemcitabine
Keywords: Cervical 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.

GemcitabineDrug
Gemcitabine weekly x 6 wks with concurrent external radiation

Study groups in NCT00184093
Study group	Role	What they receive
Gemcitabine weekly x 6 wks with concurrent external radiation	Experimental	Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Receives: Drug: Gemcitabine

What is being measured

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

Toxicity (Number of Participants With Serious Adverse Events)
Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)
Measured: Every 3 weeks from start of study until 30 days after the last dose of treatment

Secondary outcomes (1)

Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.
Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.
Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.
Measured: Baseline to response (up to 24 months)

Timeline

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

Jun 1999May 2009

First posted16 Sep 2005 (estimated)
Study startJun 1999
Primary completionMay 2008
Study completionMay 2009

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.
Other trials for Uterine Cervical CancerStudies of the same condition, open and under way.
More trials run by University of Southern CaliforniaThe 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00184093
Sponsor's protocol ID: 5C-99-1
Status last verified: Jul 2017
First submitted: 12 Sep 2005
Last updated: 15 Aug 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
Cervical Cancer Screening
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer

All Uterine Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma: Analysis of Prognostic Factors and Determinants of Response: A Pilot Study
ClinicalTrials.gov ID: NCT00184093
Acronym / sponsor ID: 5C-99-1
Conditions: Uterine Cervical Cancer
Keywords: Cervical Carcinoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Study start: Jun 1999
Primary completion: May 2008 (actual)
Study completion: May 2009 (actual)
First posted: 16 Sep 2005 (estimated)
Results: Posted 15 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gemcitabine weekly x 6 wks with concurrent external radiation	Experimental	Drug: GemcitabineGemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients with histologically confirmed bulky stage Ib or stage IIa cervical cancer. Bulky stage Ib disease is defined as tumor mass greater than 4 cms in diameter.
Cervical lesion which is measurable by physical examination.
No prior therapy for invasive cervical cancer.
GOG performance status 0-2
Signed informed consent

Key exclusion criteria (6 listed)

Patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years.
Pregnant or lactating women. Women of reproductive age may not participate unless they have agreed to use an effective method of birth control.
Patients with uncontrolled infection.
Patients who are HIV positive
Patients with psychiatric or social conditions that would interfere with consent or follow-up.

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
GemcitabineGemcitabine weekly x 6 wks with concurrent external radiation	Drug	Gemcitabine weekly x 6 wks with concurrent external radiation

Primary outcome

Toxicity (Number of Participants With Serious Adverse Events)
Time frame: Every 3 weeks from start of study until 30 days after the last dose of treatment
Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)

1 secondary outcome

Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
Time frame: Baseline to response (up to 24 months)

Results and safety

Results posted to the registry on 15 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemcitabine Weekly x 6 Wks With Concurrent External Radiation	35	26

Primary outcome: Toxicity (Number of Participants With Serious Adverse Events)

Time frame: Every 3 weeks from start of study until 30 days after the last dose of treatment. Count of participants. Unit: Participants

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation n = 35
Value	10

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine Weekly x 6 Wks With Concurrent External Radiation	10 of 35 (28.6%)	33 of 35 (94.3%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Uterine Cervical Cancer

RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
Cervical Cancer Screening
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer

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.

Lynda Roman, MD principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gemcitabine in people with Uterine Cervical Cancer, run by University of Southern California 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 9 inclusion and 6 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 15 Aug 2017. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 15 Aug 2017). 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?

Toxicity (Number of Participants With Serious Adverse Events) (time frame: Every 3 weeks from start of study until 30 days after the last dose of treatment). 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 NCT00184093.

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 15 Aug 2017.