NCT00005840

Brief Summary

This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 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

June 2, 2000

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

9 years

First QC Date

June 2, 2000

Last Update Submit

December 29, 2014

Conditions

Endometrial Clear Cell AdenocarcinomaEndometrial Serous AdenocarcinomaStage III Uterine Corpus CancerStage IV Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (2)

  • Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0

    Calculated using a 90% conditional likelihood-based confidence bound.

    Up to 30 days post-radiotherapy

  • Chronic toxicity based on the NCI CTC Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme

    Up to 6 months post-radiotherapy

Secondary Outcomes (2)

  • Number of dose level combinations that will have been evaluated prior to MTD establishment

    Up to 60 months

  • Site (local/distant) of treatment failure

    Up to 5 years

Study Arms (1)

Treatment (paclitaxel, cisplatin, abdominal radiotherapy)

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks. Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the 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. Once the MTD is determined, additional patients are treated at that dose level.

Drug: PaclitaxelDrug: CisplatinRadiation: Radiation Therapy

Interventions

PaclitaxelDRUG

Given IV

Also known as: Anzatax, TAX
Treatment (paclitaxel, cisplatin, abdominal radiotherapy)
CisplatinDRUG

Given IV

Treatment (paclitaxel, cisplatin, abdominal radiotherapy)
Radiation TherapyRADIATION

Undergo whole abdominal radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT
Treatment (paclitaxel, cisplatin, abdominal radiotherapy)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed surgical stage III or IV endometrial cancer
  • Any stage clear or serous papillary endometrial cancer
  • Positive para-aortic lymph nodes allowed
  • Tumor must be surgically reduced to 2 cm or less within 8 weeks of study
  • Must have had hysterectomy and bilateral salpingo-oophorectomy
  • No recurrent disease
  • No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes
  • Performance status - GOG 0-2
  • Absolute neutrophil count greater than 2,000/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 3 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer
  • No prior chemotherapy
  • +4 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

Interventions

PaclitaxelTaxesCisplatinRadiotherapyRadiation

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeuticsPhysical Phenomena

Study Officials

  • D. McMeekin

    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

June 2, 2000

First Posted

January 27, 2003

Study Start

July 1, 2000

Primary Completion

July 1, 2009

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

US(1)