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Phase II Study in Patients With Epidermal Growth Factor Receptor (EGFR) + Advanced Stage Ovarian, Primary Peritoneal and Fallopian Tube Cancer

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00063401
First received: June 25, 2003
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Biological: Cetuximab:
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the toxicity of the combination regimen in this subject population. [ Time Frame: Length of time for a response to treatment ] [ Designated as safety issue: Yes ]
  • To access EGFR expression by immunohistochemical assay. [ Time Frame: Length of time for a response to treatment ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: September 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Biological: Cetuximab:
400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
Other Name: Erbitux
Drug: Paclitaxel
175 mg/m2 Day 1, six 21-day cycles
Drug: Carboplatin
AUC = 6 Day1, six 21-day cycles

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Subjects must have signed an approved informed consent.
  2. 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
  3. 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.
  4. Subjects with tumor tissue available for assessment of EGFR status by IHC.
  5. EGFR expression must be positive (e.g., 1+).
  6. Subjects must have a Karnofsky Performance Status (KPS) of ≥ 70%.
  7. Subjects must be entered no more than 12 weeks postoperatively.
  8. Women, ages 18 and older.
  9. 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.
  10. Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN), CTC grade 1.
  11. Hepatic function: bilirubin ≤ 1.5 x ULN, CTC grade 1. AST ≤ 2.5 x ULN, CTC grade 1.
  12. Neurologic function: neuropathy (sensory) ≤ CTC grade 1.

Exclusion Criteria

  1. 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.
  2. WOCBP using a prohibited contraceptive method.
  3. Women who are pregnant or breastfeeding
  4. Women with a positive pregnancy test on enrollment or prior to study drug administration.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. Subjects with acute hepatitis.
  10. Subjects with active or uncontrolled infection are not eligible.
  11. Subjects with a significant history of cardiac disease, i.e., uncontrolled hypertension,unstable angina, and congestive heart failure.
  12. Subjects with left ventricular ejection fraction (LVEF) below the institutional range of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram.
  13. A history of prior cetuximab or other therapy which targets the EGFR pathway or a history of prior chimerized or murine monoclonal antibody therapy.
  14. Subjects with a known allergy to murine proteins or Cremophor EL.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063401

Locations
United States, New York
ImClone Investigational Site
New York, New York, United States, 10021
United States, Pennsylvania
ImClone Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
Study Director: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

No publications provided

Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00063401     History of Changes
Obsolete Identifiers: NCT00070044
Other Study ID Numbers: CA225-009
Study First Received: June 25, 2003
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by ImClone LLC:
ovarian
primary peritoneal cancer
fallopian tube cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Carboplatin
Cetuximab
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014