Suspended

A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

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What is being tested

Cetuximab

Biological
Who is being recruted

Ovarian Cancer

Over 18 Years
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2004

See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: April 9, 2010
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma. To determine the overall response rate of cetuximab alone in subjects with ovarian or primary peritoneal carcinoma who have persistent or recurrent disease following 1-2 previous regimens of chemotherapy. Potential relationship between response, dose, and the occurence of rash in the treatment of subjects who have stable disease after the initial 6 weeks of treatment, time to progression, and 1 yr survival.

Official TitleA Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma 
Principal SponsorEli Lilly and Company
Last updated: April 9, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Ovarian Cancer
Criteria
6 inclusion criteria required to participate
subjects must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the original primary tumor is required
EGFR expression must be positive as determined by an outside reference lab
Subjects must have had a treatment-free interval following platinum of <12 mos
All subjects must have measurable disease at baseline

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5 exclusion criteria prevent from participating
Subjects with other invasive malignancies (including peritoneal mesotheliomas)
Subjects with unstable cardiac disease or MI within 6 mos
Subjects with Acute hepatitis
Subjects with active or uncontrolled infection

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
ImClone Investigational SiteBirmingham, United StatesSee the location
Suspended
ImClone Investigational SiteOrlando, United States
Suspended
ImClone Investigational SiteNew York, United States
Suspended
ImClone Investigational SitePhiladelphia, United States
Suspended5 Study Centers