Brief Title
Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
Official Title
A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Sometimes after treatment, the tumor may not need additional
treatment until it progresses. In this case, observation may be sufficient. It is not yet
known whether erlotinib is more effective than observation after first-line chemotherapy in
treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works
compared to observation in treating patients who have undergone first-line chemotherapy for
ovarian cancer, peritoneal cancer, or fallopian tube cancer.
Detailed Description
OBJECTIVES:
Primary
- Compare the benefits, in terms of progression-free survival, of maintenance therapy
comprising erlotinib vs observation in patients with responding or stable disease after
first-line, platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian
epithelial, primary peritoneal, or fallopian tube cancer.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Determine the safety of erlotinib in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (I-II vs III-IV), participating center, age (≤ 65 vs > 65), response to
first-line therapy (no evidence of disease/complete response vs partial response vs stable
disease), and first-line therapy (platinum-based vs platinum/taxane combination vs
platinum-based triplet). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral erlotinib once daily for up to 2 years in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation as per standard of care. Quality of life is
assessed at baseline and then every 3 months for up to 2 years.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 830 patients will be accrued for this study.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Overall survival
Condition
Fallopian Tube Cancer
Intervention
erlotinib hydrochloride
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
835
Start Date
September 2005
Primary Completion Date
February 2008
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
cancer meeting 1 of the following criteria:
- High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or
clear cell disease
- Stage II, III, or IV disease
- Completed first-line therapy within the past 6 weeks
- Received a platinum derivative (carboplatin or cisplatin) alone or in combination
with other agents for 6-9 courses
- Must have achieved complete response/no evidence of disease, partial response, or
stabilization of disease after therapy
- No adenocarcinoma of unknown origin
- No known brain metastases or leptomeningeal disease
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 2,000/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with
known liver metastases)
- Bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases
- PT and PTT ≤ 1.5 times ULN
Renal
- Creatinine ≤ 2 times ULN
Cardiovascular
- No myocardial infarction within past 6 months
- No second- or third-degree heart block without pacemaker
Gastrointestinal
- No active peptic ulcer disease
- No gastrointestinal tract disease that would interfere with ability to take oral
medications, affect absorption, or require parenteral nutrition
- No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative
colitis)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant dermatologic disease
- No inflammatory changes to the surface of the eye
- No history of allergic reaction to compounds of similar chemical composition as
erlotinib
- No other significant medical condition or neurologic or psychiatric disorder
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix
- No psychiatric illness or familial, geographic, or social situation that would
preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior therapy targeting epidermal growth factor receptor
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- See Surgery
- No concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy
Radiotherapy
- No prior radiotherapy unless completed more than 5 years ago AND outside the
abdomen/pelvis
Surgery
- Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at
the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus
Other
- No other prior or concurrent investigational agents
- No other concurrent anticancer treatment
- Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Antonio Jimeno, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00263822
Organization ID
EORTC-55041
Secondary IDs
EORTC-55041
Responsible Party
Sponsor
Study Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Antonio Jimeno, Study Chair, Hospital Universitario 12 de Octubre
Verification Date
August 2013