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

NCT ID: NCT00217529

Last Updated: 2010-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

pegfilgrastim

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

erlotinib hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Leona A. Holmberg, MD, PhD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Dan Veljovich, MD

Role: STUDY_CHAIR

Pacific Gynecology Specialists

Locations

Pacific Gynecology Specialists

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University of Washington School of Medicine

Seattle, Washington, United States

Countries

United States

Other Identifiers

PSOC-2001

Identifier Type: -

Identifier Source: secondary_id

AVENTIS-PSOC-2001

Identifier Type: -

Identifier Source: secondary_id

PSOC-IRB-5689

Identifier Type: -

Identifier Source: secondary_id

CDR0000441312

Identifier Type: REGISTRY

Identifier Source: secondary_id

PSOC 2001

Identifier Type: -

Identifier Source: org_study_id