Ovarian CancerPhase 2NCT00063401
Phase II Study in Patients With Epidermal Growth Factor Receptor (EGFR) + Advanced Stage Ovarian, Primary Peritoneal and Fallopian Tube Cancer
A Phase 2 study testing Cetuximab:, Paclitaxel and Carboplatin in people with Ovarian Cancer and Peritoneal Neoplasms, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The purpose of this study is to determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Neoplasms, Fallopian Tube Neoplasms
- What is being tested?
- Cetuximab:, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to Jun 2006
- 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
- Subjects must have signed an approved informed consent.
- Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage III or IV, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation. Pathology must be verified at the participating institution
- Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- Subjects with tumor tissue available for assessment of EGFR status by IHC.
- EGFR expression must be positive (e.g., 1+).
- Subjects must have a Karnofsky Performance Status (KPS) of ≥ 70%.
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- Subjects must be entered no more than 12 weeks postoperatively.
- Women, ages 18 and older.
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/ul, equivalent to Common Toxicity Criteria (CTC) grade 1. Platelets ≥ the institutional lower limit of normal (LLN), CTC grade 0.
- Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN), CTC grade 1.
- Hepatic function: bilirubin ≤ 1.5 x ULN, CTC grade 1. AST ≤ 2.5 x ULN, CTC grade 1.
- Neurologic function: neuropathy (sensory) ≤ CTC grade 1.
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- WOCBP using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
- Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to registration, and the subject remains free of recurrent or metastatic disease.
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- Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration,and that the subject remains free of recurrent or metastatic disease.
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
- Subjects with acute hepatitis.
- Subjects with active or uncontrolled infection are not eligible.
- Subjects with a significant history of cardiac disease, i.e., uncontrolled hypertension,unstable angina, and congestive heart failure.
- Subjects with left ventricular ejection fraction (LVEF) below the institutional range of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram.
- A history of prior cetuximab or other therapy which targets the EGFR pathway or a history of prior chimerized or murine monoclonal antibody therapy.
- Subjects with a known allergy to murine proteins or Cremophor EL.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ImClone Investigational Site
New York, New York, 10021
ImClone Investigational Site
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
The purpose of this study is to determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Read the detailed description
The population being studied in this trial is subjects with advanced stage ovarian, primary peritoneal and fallopian tube cancer will be enrolled. By receiving combination therapy with cetuximab (C225)/paclitaxel/carboplatin, these subjects will experience longer progression-free survival than previously reported for subjects receiving only paclitaxel and carboplatin.
- Being tested
- Cetuximab:, Paclitaxel, Carboplatin
- Keywords
- ovarian, primary peritoneal cancer, fallopian tube cancer
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab:Biological
Also called Erbitux
400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
PaclitaxelDrug
175 mg/m2 Day 1, six 21-day cycles
CarboplatinDrug
AUC = 6 Day1, six 21-day cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cetuximab 400 mg/m2 IV (over 120 minutes) on Day 1 of Cycle 1, followed by weekly maintenance doses of 250 mg/m2 IV (over 60 minutes). Paclitaxel 175 mg/m2 IC (over 3 hours) and carboplatin AUC of 6 IV (over 30 minutes) on Day 1 of each cycle. For eligible subjects, maintenance therapy will consist of cetuximab 250 mg/m2/week for up to 6 months. Receives: Biological: Cetuximab:; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Measured: How long patients have progression-free survival
Secondary outcomes (3)
To determine clinical and/or pathological response rates with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Measured: Length of time for a response to treatment
To evaluate the toxicity of the combination regimen in this subject population.
Measured: Length of time for a response to treatment
To access EGFR expression by immunohistochemical assay.
Measured: Length of time for a response to treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2003 (estimated)
- Study startSep 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- E-mail: ClinicalTrials@ ImClone.com, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063401
- Sponsor's protocol ID
- CA225-009
- Status last verified
- Apr 2010
- First submitted
- 25 Jun 2003
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00063401
- Acronym / sponsor ID
- CA225-009
- Keywords
- ovarian, primary peritoneal cancer, fallopian tube cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 27 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Detailed description
The population being studied in this trial is subjects with advanced stage ovarian, primary peritoneal and fallopian tube cancer will be enrolled. By receiving combination therapy with cetuximab (C225)/paclitaxel/carboplatin, these subjects will experience longer progression-free survival than previously reported for subjects receiving only paclitaxel and carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Cetuximab:, Drug: Paclitaxel, Drug: CarboplatinCetuximab 400 mg/m2 IV (over 120 minutes) on Day 1 of Cycle 1, followed by weekly maintenance doses of 250 mg/m2 IV (over 60 minutes). Paclitaxel 175 mg/m2 IC (over 3 hours) and carboplatin AUC of 6 IV (over 30 minutes) on Day 1 of each cycle. For eligible subjects, maintenance therapy will consist of cetuximab 250 mg/m2/week for up to 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must have signed an approved informed consent.
- Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage III or IV, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation. Pathology must be verified at the participating institution
- Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
- Subjects with tumor tissue available for assessment of EGFR status by IHC.
- EGFR expression must be positive (e.g., 1+).
Key exclusion criteria (14 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- WOCBP using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab:Also: Erbitux400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles | Biological | 1 |
| Paclitaxel175 mg/m2 Day 1, six 21-day cycles | Drug | 1 |
| CarboplatinAUC = 6 Day1, six 21-day cycles | Drug | 1 |
Primary outcome
To determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Time frame: How long patients have progression-free survival
3 secondary outcomes
To determine clinical and/or pathological response rates with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
Time frame: Length of time for a response to treatment
To evaluate the toxicity of the combination regimen in this subject population.
Time frame: Length of time for a response to treatment
To access EGFR expression by immunohistochemical assay.
Time frame: Length of time for a response to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E-mail: ClinicalTrials@ ImClone.com study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab:, Paclitaxel and Carboplatin in people with Ovarian Cancer and Peritoneal Neoplasms, run by Eli Lilly and Company at 2 sites 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 12 inclusion and 14 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 8 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer. (time frame: How long patients have progression-free survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2010.