NCT00031993

Brief Summary

This phase II trial is studying erlotinib to see how well it works in treating patients with persistent or recurrent cancer of the cervix. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor

Trial Health

80
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

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

Study Start

First participant enrolled

March 1, 2002

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

March 8, 2002

Last Update Submit

January 16, 2013

Conditions

Cervical Squamous Cell CarcinomaRecurrent Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    At 6 months

  • Frequency and severity of adverse effects as measured by NCI CTC version 3.0

    Up to 5 years

Secondary Outcomes (4)

  • Duration of overall survival

    Up to 5 years

  • Duration of progression-free survival

    Up to 5 years

  • Frequency of clinical response (complete and partial)

    Up to 5 years

  • Prognostic factors including initial performance status and age

    Up to 5 years

Study Arms (1)

Treatment (erlotinib hydrochloride)

EXPERIMENTAL

Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochlorideOther: laboratory biomarker analysis

Interventions

erlotinib hydrochlorideDRUG

Given PO

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (erlotinib hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (erlotinib hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed squamous cell carcinoma (SCC) of the cervix
  • Persistent or recurrent progressive disease
  • At least 1 prior systemic chemotherapy regimen for management of advanced, metastatic, or recurrent SCC of the cervix is required
  • Chemotherapy administered as a radiosensitizer in conjunction with radiotherapy does not count as a systemic chemotherapy regimen
  • At least 1 unidimensionally measurable target lesion
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Lesions within a previously irradiated field are considered nontarget lesions unless disease progression or persistence is confirmed ≥ 90 days after completion of radiotherapy
  • Tumor accessible for repeat needle biopsy
  • Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (any active GOG phase III protocol for the same patient population)
  • Performance status - GOG 0-2 (for patients who have received only 1 prior regimen)
  • Performance status - GOG 0-1 (for patients who have received 2 prior regimens)
  • Platelet count at least 100,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • +30 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

Erlotinib Hydrochloride

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)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Russell Schilder

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Primary Completion

November 1, 2005

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)