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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pegfilgrastim
carboplatin
docetaxel
erlotinib hydrochloride
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Gynecology Specialists
  • Fred Hutchinson Cancer Research Center
  • University of Washington School of Medicine

Outcomes

Primary Outcome Measures

Maximum tolerated dose of erlotinib

Secondary Outcome Measures

Toxicity of maintenance therapy
Proportion of patients who receive the full schedule of treatment courses
Response rate
Progression-free survival
Overall survival

Full Information

First Posted
September 20, 2005
Last Updated
September 20, 2010
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00217529
Brief Title
Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Primary Outcome Measure Information:
Title
Maximum tolerated dose of erlotinib
Secondary Outcome Measure Information:
Title
Toxicity of maintenance therapy
Title
Proportion of patients who receive the full schedule of treatment courses
Title
Response rate
Title
Progression-free survival
Title
Overall survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leona A. Holmberg, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dan Veljovich, MD
Organizational Affiliation
Pacific Gynecology Specialists
Official's Role
Study Chair
Facility Information:
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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