Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00263822 |
|
Recruitment Status :
Completed
First Posted : December 9, 2005
Last Update Posted : August 27, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer | Drug: erlotinib hydrochloride | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 835 participants |
| Allocation: | Randomized |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | February 2008 |
- Progression-free survival
- Overall survival
- Adverse event profile
- Quality of life
- Cutaneous toxicity (rash or acne [papulo-pustular rash])
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263822
Show 92 study locations
| Study Chair: | Antonio Jimeno | Hospital Universitario 12 de Octubre |
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00263822 |
| Other Study ID Numbers: |
EORTC-55041 EORTC-55041 EUDRACT-2004-004333-34 |
| First Posted: | December 9, 2005 Key Record Dates |
| Last Update Posted: | August 27, 2013 |
| Last Verified: | August 2013 |
|
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer primary peritoneal cavity cancer fallopian tube cancer |
|
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms |
Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Fallopian Tube Diseases Erlotinib Hydrochloride Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |