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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: pegfilgrastim Drug: carboplatin Drug: docetaxel Drug: erlotinib hydrochloride |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
- Maximum tolerated dose of erlotinib [ Designated as safety issue: Yes ]
- Toxicity of maintenance therapy [ Designated as safety issue: Yes ]
- Proportion of patients who receive the full schedule of treatment courses [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Study Start Date: | June 2004 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Pacific Gynecology Specialists | |
| Seattle, Washington, United States, 98104 | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98195 | |
| Study Chair: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
| Study Chair: | Dan Veljovich, MD | Pacific Gynecology Specialists |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00217529 History of Changes |
| Other Study ID Numbers: | PSOC 2001, PSOC-2001, AVENTIS-PSOC-2001, PSOC-IRB-5689, CDR0000441312 |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 20, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Docetaxel Carboplatin Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013