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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217529
• Other study ID #: PSOC 2001
• Secondary ID: PSOC-2001AVENTIS
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 20, 2005
• Last updated: September 20, 2010
• Start date: June 2004

Study information

• Verified date: September 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Biological:
• pegfilgrastim

Drug:
• carboplatin

• docetaxel

• erlotinib hydrochloride

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Pacific Gynecology Specialists	Seattle	Washington
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of erlotinib			Yes
Secondary	Toxicity of maintenance therapy			Yes
Secondary	Proportion of patients who receive the full schedule of treatment courses			No
Secondary	Response rate			No
Secondary	Progression-free survival			No
Secondary	Overall survival			No