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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Treatments: Carboplatin; Docetaxel; Erlotinib Hydrochloride

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