NCT00003385

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

May 27, 2013

Status Verified

September 1, 2003

Enrollment Period

7.8 years

First QC Date

November 1, 1999

Last Update Submit

May 24, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerovarian undifferentiated adenocarcinomaovarian mixed epithelial carcinomaovarian serous cystadenocarcinomaovarian mucinous cystadenocarcinomaovarian endometrioid adenocarcinomaovarian clear cell cystadenocarcinomafallopian tube cancerprimary peritoneal cavity cancerBrenner tumor

Interventions

carboplatinDRUG
paclitaxelDRUG
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma * The following histologic epithelial cell types are eligible: * Serous adenocarcinoma * Endometrioid adenocarcinoma * Mucinous adenocarcinoma * Undifferentiated carcinoma * Clear cell adenocarcinoma * Mixed epithelial carcinoma * Transitional cell * Malignant Brenner tumor * Adenocarcinoma not otherwise specified * No more than 12 weeks since diagnosis * No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas) PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT/SGPT no greater than 3 times normal * Alkaline phosphatase no greater than 3 times normal * Gamma-glutamyl-transferase no greater than 3 times normal * No acute hepatitis Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance greater than 50 mL/min Cardiovascular: * LVEF normal by MUGA * No unstable angina * No myocardial infarction within the past 6 months * Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if disease has been stable for the past 6 months Other: * No septicemia or severe infection * No severe gastrointestinal bleeding * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Recovered from recent prior surgery Other: * No prior anticancer therapy that would preclude study

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

Sponsors & Collaborators

Study Sites (8)

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (2)

  • Rose PG, Greer BE, Horowitz IR, Markman M, Fusco N. Paclitaxel, carboplatin and pegylated liposomal doxorubicin in ovarian and peritoneal carcinoma: a phase I study of the Gynecologic Oncology Group. Gynecol Oncol. 2007 Jan;104(1):114-9. doi: 10.1016/j.ygyno.2006.07.036. Epub 2006 Sep 7.

    PMID: 16959305RESULT

  • Rose PG, Greer BE, Markman M, et al.: A phase I study of paclitaxel, carboplatin, and liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: a Gynecologic Oncology Group Study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-1531, 2000.

    RESULT

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian EpithelialBrenner Tumor

Interventions

CarboplatinPaclitaxel

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, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Peter G. Rose, MD

    MetroHealth Cancer Care Center at MetroHealth Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1999

Primary Completion

January 1, 2007

Last Updated

May 27, 2013

Record last verified: 2003-09

Locations

NO(1)US(7)