NCT00217555

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cavity cancer.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

July 1, 2002

Completed
3.2 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

3.6 years

First QC Date

September 20, 2005

Last Update Submit

September 20, 2010

Conditions

Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerfallopian tube cancerperitoneal cavity cancer

Outcome Measures

Primary Outcomes (3)

  • Toxicity

  • Response rate

  • Quality of life

Secondary Outcomes (2)

  • Progression-free survival

  • Overall survival

Interventions

gemcitabine hydrochlorideDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer * Recurrent or persistent platinum-refractory disease, as defined by 1 of the following: * Progressive disease while on a platinum compound * Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy * Recurrent disease within 6 months after completion of therapy * Measurable or evaluable disease * Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests) * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-3 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN * Creatinine clearance \> 50 mL/min Other * No clinically significant infection * No other severe medical condition that would preclude study treatment * 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 * Not specified Chemotherapy * See Disease Characteristics * Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug * At least 3 weeks since prior chemotherapy and recovered Endocrine therapy * Not specified Radiotherapy * At least 3 weeks since prior radiotherapy and recovered Surgery * Recovered from recent prior surgery

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

Sponsors & Collaborators

Study Sites (1)

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Goff BA, Holmberg LA, Veljovich D, Kurland BF; Puget Sound Oncology Consortium. Treatment of recurrent or persistent platinum-refractory ovarian, fallopian tube or primary peritoneal cancer with gemcitabine and topotecan: a phase II trial of the Puget Sound Oncology Consortium. Gynecol Oncol. 2008 Aug;110(2):146-51. doi: 10.1016/j.ygyno.2008.04.037. Epub 2008 Jun 6.

    PMID: 18538834RESULT

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

GemcitabineTopotecan

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 Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloids

Study Officials

  • Barbara A. Goff, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

July 1, 2002

Primary Completion

February 1, 2006

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(1)