NCT00217529

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

1.4 years

First QC Date

September 20, 2005

Last Update Submit

September 20, 2010

Conditions

Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer

Keywords

stage III ovarian epithelial cancerstage IV ovarian epithelial cancerperitoneal cavity cancerovarian clear cell cystadenocarcinomaovarian endometrioid adenocarcinomaovarian undifferentiated adenocarcinomaovarian mucinous cystadenocarcinomaovarian serous cystadenocarcinomaBrenner tumorfallopian tube cancerovarian mixed epithelial carcinoma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of erlotinib

Secondary Outcomes (5)

  • Toxicity of maintenance therapy

  • Proportion of patients who receive the full schedule of treatment courses

  • Response rate

  • Progression-free survival

  • Overall survival

Interventions

pegfilgrastimBIOLOGICAL
carboplatinDRUG
docetaxelDRUG
erlotinib hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian EpithelialBrenner Tumor

Interventions

pegfilgrastimCarboplatinDocetaxelErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Leona A. Holmberg, MD, PhD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

  • Dan Veljovich, MD

    Pacific Gynecology Specialists

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Primary Completion

November 1, 2005

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(3)