Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

Study Overview
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Brief Summary
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RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with docetaxel and carboplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel and carboplatin and to see how well they work in treating patients with newly diagnosed stage III or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.

Detailed Description
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OBJECTIVES: Primary Determine the maximum tolerated dose (MTD) of erlotinib when administered in combination with docetaxel and carboplatin as front-line therapy in patients with newly diagnosed stage III or IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Secondary Determine the toxicity of maintenance therapy with erlotinib when administered after front-line therapy in these patients. Determine the proportion of patients who are able to receive the full schedule of treatment courses. Determine the objective response rate in patients with measurable or evaluable disease treated with this regimen. Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Front-line therapy: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, pegfilgrastim subcutaneously on day 2, and oral erlotinib once daily on days 3-16. Treatment repeats every 21 days for up to 6 courses. Cohorts of 5 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity. Maintenance therapy: Beginning 3-4 weeks after the completion of front-line therapy, patients with stable or responding disease receive oral erlotinib once daily for up to 12 months. After completion of study treatment, patients are followed every 6 months for 1 year and then periodically thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
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A Phase I-II Study of OSI-774 (Tarceva, Erlotinib) With Docetaxel/Carboplatin Followed by Maintenance Therapy With Tarceva as Treatment for Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: pegfilgrastim
* Drug: carboplatin
* Drug: docetaxel
* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer Stage III or IV disease The following histologic epithelial cell types are allowed: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Endometrioid adenocarcinoma Mixed epithelial carcinoma Undifferentiated carcinoma Transitional cell carcinoma Malignant Brenner tumor Adenocarcinoma not otherwise specified Must have undergone appropriate surgery for ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer within the past 6 weeks No borderline ovarian tumor of low malignant potential PATIENT CHARACTERISTICS: Age 18 and over Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST or ALT normal No hepatic disease that would preclude study participation Renal Creatinine ≤ 2.0 mg/dL Creatinine clearance > 50 mL/min No renal disease that would preclude study participation Cardiovascular LVEF ≥ lower limit of normal* No poorly controlled arrhythmia No unstable coronary artery disease No myocardial infarction within the past year NOTE: *LVEF evaluation performed only on patients requiring it Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No other nonmalignant systemic disease that would preclude study participation No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No medical, social, or psychosocial factor that would preclude study participation No psychiatric or addictive disorder that would preclude giving informed consent No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for this malignancy Chemotherapy No prior chemotherapy for this malignancy Endocrine therapy No prior hormonal therapy for this malignancy Radiotherapy No prior radiotherapy for this malignancy Surgery See Disease Characteristics No planned interval cytoreductive surgery Second-look surgery allowed Other More than 1 year since prior experimental or investigational therapy No concurrent therapeutic anticoagulation with warfarin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pegfilgrastim|nan|
|Drug: carboplatin|nan|
|Drug: docetaxel|nan|
|Drug: erlotinib hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of erlotinib |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of maintenance therapy |  |  | 
| Proportion of patients who receive the full schedule of treatment courses |  |  | 
| Response rate |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian undifferentiated adenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, Brenner tumor, fallopian tube cancer, ovarian mixed epithelial carcinoma