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Cervical Squamous Cell CarcinomaPhase 2NCT00031993

Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix

A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Cervical Squamous Cell Carcinoma and Recurrent Cervical Cancer, run by National Cancer Institute (NCI) 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 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
erlotinib hydrochloride and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
Mar 2002to Nov 2005
Phase
Phase 2
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 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
Show all 45Show fewer
  • 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
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No abnormalities of the cornea (e.g., dry eye syndrome or Sjogren's syndrome)
  • No congenital abnormalities (e.g., Fuch's dystrophy)
  • No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No uncontrolled concurrent illness
  • No ongoing or active infection requiring IV antibiotics
  • No psychiatric illness or social situation that would preclude study compliance
  • No grade 2 or greater sensory or motor neuropathy
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • At least 3 weeks since prior immunologic therapy for SCC of the cervix
  • One additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease allowed
  • At least 3 weeks since prior chemotherapy for SCC of the cervix and recovered
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • At least 3 weeks since prior hormonal therapy for SCC of the cervix
  • At least 3 weeks since prior radiotherapy for SCC of the cervix and recovered
  • Recovered from recent prior surgery
  • At least 3 weeks since other prior therapy for SCC of the cervix
  • No prior epidermal growth factor receptor-targeting therapies
  • No prior anticancer treatment that would preclude study participation
  • No other concurrent investigational or commercial agents or therapies for SCC of the cervix

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 II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the antitumor cytostatic activity of OSI-774 as measured by the probability of surviving progression-free for at least 6 months in patients with persistent or recurrent squamous cell carcinoma of the cervix.

II. To determine the nature and degree of toxicity of OSI-774 in this cohort of patients.

SECONDARY OBJECTIVES:

  1. To determine the partial and complete response rates in patients with squamous cell carcinoma of the cervix receiving OSI-774.

II. To determine the duration of progression-free survival and overall survival within this patient population treated with OSI-774.

III. Assess the effects of prognostic factors: initial performance status and age.

TERTIARY OBJECTIVES:

  1. To determine epidermal growth factor receptor (EGFR) and p110 truncated EGFR (p110 sEGFR) isoform expression levels in primary tumors, and from tumor samples obtained pretreatment and following four weeks of therapy to determine tumor response (or resistance) to OSI-774 inhibition of the EGFR tyrosine kinase.

II. To correlate EGFR and p110sEGFR expression levels with either MAPK or AKT phosphorylation status in the same tissue samples obtained pretreatment and following four weeks of drug treatment to determine downstream effects with response to OSI-774 inhibition of EGFR.

III. To determine whether pretreatment serum p110 sEGFR concentrations are a useful prognostic indicator and whether altered and/or sEGFR concentrations are useful indicators of therapeutic responsiveness, time to progression, and overall survival in cervical carcinoma patients.

OUTLINE: This is a multicenter study.

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

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

Being tested
erlotinib hydrochloride, laboratory biomarker analysis
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.

  • erlotinib hydrochlorideDrug

    Also called CP-358,774, erlotinib, OSI-774

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00031993
Study groupRoleWhat they receive
Treatment (erlotinib hydrochloride)ExperimentalPatients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

What is being measured

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

  1. Progression-free survival

    Measured: At 6 months

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

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Duration of overall survival

    Measured: Up to 5 years

  2. Duration of progression-free survival

    Measured: Up to 5 years

  3. Frequency of clinical response (complete and partial)

    Measured: Up to 5 years

  4. Prognostic factors including initial performance status and age

    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 posted27 Jan 2003 (estimated)
  2. Study startMar 2002
  3. Primary completionNov 2005

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00031993
Sponsor's protocol ID
NCI-2012-02457
Other IDs
GOG-0227D, U10CA027469, CDR0000069247
Status last verified
Jan 2013
First submitted
8 Mar 2002
Last updated
17 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride and laboratory biomarker analysis in people with Cervical Squamous Cell Carcinoma and Recurrent Cervical Cancer, run by National Cancer Institute (NCI) 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 45 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 17 Jan 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression-free survival (time frame: At 6 months). The study lists 2 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 NCT00031993.

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 17 Jan 2013.

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