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Cervical CancerPhase 1NCT00287911

Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

A Phase 1 study testing cisplatin, topotecan hydrochloride and brachytherapy in people with Cervical Cancer, run by Masonic Cancer Center, University of Minnesota 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

RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
cisplatin, topotecan hydrochloride and brachytherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Feb 2005to Dec 2009
Phase
Phase 1
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed cervical carcinoma
  • Deemed not curable by surgery or radiotherapy alone
  • The following stages are eligible:
  • Stage IIB
  • Stage IIIA or IIIB
  • Stage IVA
Show all 30Show fewer
  • Stage IB or IIA with ≥ 1 of the following risk factors:
  • Primary tumor ≥ 6 cm
  • Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
  • Positive surgical margins
  • Depth of invasion > 50% and positive capillary-lymphatic space involvement
  • The following histologic subtypes are eligible:
  • Squamous
  • Adenosquamous
  • Adenocarcinoma
  • No recurrent cervical cancer
  • Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
  • White blood cells (WBC) ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Granulocyte count ≥ 1,500/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 1.5 times institutional normal
  • Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase ≤ 3 times institutional normal
  • No other prior or concurrent malignancies other than skin (excluding melanoma)
  • No septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction
  • No anatomic abnormalities (e.g., pelvic kidney or renal transplant) requiring modification of radiation fields
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) are eligible if disease is stable for the past 6 months
  • Recovered from recent surgery

Who cannot join

  • Prior pelvic radiation
  • Pregnant or nursing
  • History of thrombus
  • History of unstable angina or myocardial infarction within the past 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of topotecan when administered with cisplatin in patients with advanced cervical cancer.
  • Identify any unique toxicities associated with administering radiotherapy along with adjuvant cisplatin and topotecan in patients with cervical cancer.
  • Determine the feasibility of administering continuous infusion topotecan chemotherapy together with radiation therapy.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of topotecan.

Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Quality of life is assessed at baseline and at 4 and 14 weeks after completion of study treatment.

After completion of study treatment, patients are followed periodically.

Conditions
Cervical Cancer
Being tested
cisplatin, topotecan hydrochloride, brachytherapy, radiation therapy
Keywords
cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer
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.

  • cisplatinDrug

    Also called cisplatinum, CDDP, Platinol AQ

    intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36

  • topotecan hydrochlorideDrug

    Also called Hycamtin

    intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined

  • brachytherapyRadiation

    Some patients may also undergo brachytherapy

  • radiation therapyRadiation

    Also called radiation

    once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36

Study groups in NCT00287911
Study groupRoleWhat they receive
Combo Chemotherapy and RadiationExperimentalPatients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Receives: Drug: cisplatin; Drug: topotecan hydrochloride; Radiation: brachytherapy; Radiation: radiation therapy

What is being measured

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

  1. Maximum tolerated dose of topotecan

    Adequate Response Trial Minimum length of trial to evaluate response is defined as receiving the first course of chemotherapy and living at least three weeks for repeat measurement to be performed.

    Measured: Week 3 After First Course of Therapy

Timeline

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

  1. First posted7 Feb 2006 (estimated)
  2. Study startFeb 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287911
Sponsor's protocol ID
CDR0000452043
Other IDs
UMN-2001LS041, UMN-WCC-34, 104864/638
Status last verified
Nov 2017
First submitted
6 Feb 2006
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cisplatin, topotecan hydrochloride and brachytherapy in people with Cervical Cancer, run by Masonic Cancer Center, University of Minnesota 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 30 inclusion and 4 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 2 Dec 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 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.

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?

Maximum tolerated dose of topotecan (time frame: Week 3 After First Course of Therapy). 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 NCT00287911.

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 2 Dec 2017.

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