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Cervical AdenocarcinomaPhase 1NCT00068549

Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer

A Phase 1 study testing Gemcitabine Hydrochloride, Cisplatin and Radiation Therapy in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group 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

This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Gemcitabine Hydrochloride, Cisplatin and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Oct 2003to Jan 2008
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed primary invasive carcinoma of the uterine cervix
  • Previously untreated disease
  • Any cell type
  • Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA
  • Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy
  • No known metastases to scalene nodes or other organs outside the radiotherapy field
Show all 23Show fewer
  • Study enrollment within 8 weeks of diagnosis
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Creatinine less than 2.0 mg/dL
  • No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields
  • No ureteral obstruction allowed unless treated with stent or nephrostomy tube
  • Not pregnant
  • Fertile patients must use effective contraception
  • No septicemia or severe infection
  • No circumstance that would preclude study completion or follow-up
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior cytotoxic chemotherapy
  • No prior pelvic or abdominal radiotherapy
  • No prior therapy for this malignancy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase I Study of Whole Pelvic Radiation Therapy With Concomitant Cisplatin and Gemcitabine Chemotherapy in Patients With Cervical Carcinoma (Stages I-IV) Limited to the Pelvis

This phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis.

II. Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients.

SECONDARY OBJECTIVES:

  1. Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.

II. Determine the site of recurrence, local versus distant, in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine.

Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity.

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

Being tested
Gemcitabine Hydrochloride, Cisplatin, Radiation Therapy, Internal Radiation Therapy
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.

  • Gemcitabine HydrochlorideDrug

    Also called dFdC, dFdCyd

    Given IV

  • CisplatinDrug

    Given IV

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation

    Undergo whole pelvis radiotherapy

  • Internal Radiation TherapyRadiation

    Also called Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

    Undergo brachytherapy

Study groups in NCT00068549
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks.
Receives: Drug: Gemcitabine Hydrochloride; Drug: Cisplatin; Radiation: Radiation Therapy; Radiation: Internal Radiation Therapy

What is being measured

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

  1. Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0

    Measured: Up to 30 days after completion of radiation therapy

  2. Incidence of chronic toxicity using the CTC RTOG/EORTC late radiation morbidity scoring scheme

    Measured: Up to 5 years

  3. Dose of each drug

    Measured: Up to 5 years

  4. Number of cycles received

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Site (local/distant) of treatment failure

    Measured: Up to 5 years

  2. Progression-free survival

    Measured: Up to 5 years

  3. Overall survival

    Measured: Up to 5 years

Timeline

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

  1. First posted11 Sep 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionJan 2008

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
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068549
Sponsor's protocol ID
GOG-9912
Other IDs
NCI-2012-02553, CDR0000327715, GOG-9912, GOG-9912, U10CA027469
Status last verified
Dec 2014
First submitted
10 Sep 2003
Last updated
25 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine Hydrochloride, Cisplatin and Radiation Therapy in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group 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 23 inclusion and 0 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 25 Dec 2014. 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?

Incidence of acute toxicity using the 21 major categories of the CTEP CTC version 2.0 (time frame: Up to 30 days after completion of radiation therapy). The study lists 4 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 NCT00068549.

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 25 Dec 2014.

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