NCT00068549

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

September 10, 2003

Last Update Submit

December 23, 2014

Conditions

Cervical AdenocarcinomaCervical Adenosquamous CarcinomaCervical Small Cell CarcinomaCervical Squamous Cell CarcinomaStage IB Cervical CancerStage IIA Cervical CancerStage IIB Cervical CancerStage III Cervical CancerStage IVA Cervical Cancer

Outcome Measures

Primary Outcomes (4)

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

    Up to 30 days after completion of radiation therapy

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

    Up to 5 years

  • Dose of each drug

    Up to 5 years

  • Number of cycles received

    Up to 5 years

Secondary Outcomes (3)

  • Site (local/distant) of treatment failure

    Up to 5 years

  • Progression-free survival

    Up to 5 years

  • Overall survival

    Up to 5 years

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: Gemcitabine HydrochlorideDrug: CisplatinRadiation: Radiation TherapyRadiation: Internal Radiation Therapy

Interventions

Gemcitabine HydrochlorideDRUG

Given IV

Also known as: dFdC, dFdCyd
Treatment
CisplatinDRUG

Given IV

Treatment
Radiation TherapyRADIATION

Undergo whole pelvis radiotherapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT
Treatment
Internal Radiation TherapyRADIATION

Undergo brachytherapy

Also known as: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy
Treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

GemcitabineCisplatinRadiotherapyRadiationBrachytherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeuticsPhysical Phenomena

Study Officials

  • Peter Rose

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

October 1, 2003

Primary Completion

January 1, 2008

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations

US(1)