NCT00006267

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

July 9, 2013

Status Verified

May 1, 2004

First QC Date

September 11, 2000

Last Update Submit

July 8, 2013

Conditions

Ovarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerprimary peritoneal cavity cancer

Interventions

rubitecanDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer * Measurable disease * Ascites and pleural effusions are not considered measurable * Sonography allowed if bidimensionally measurable * Must not be eligible for higher priority GOG protocol 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 * Granulocyte count at least 1,500/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and alkaline phosphatase no greater than 3 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Other: * No other prior or concurrent invasive malignancy in the past 5 years except nonmelanoma skin cancer * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least but no more than 2 prior chemotherapy regimens containing carboplatin, cisplatin, or another organoplatinum compound combined with paclitaxel * Second line therapy may include any agents except topoisomerase I inhibitors (i.e., topotecan) * No prior nitrocamptothecin or topoisomerase I inhibitors * At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * At least 3 weeks since prior surgery and recovered Other: * No prior cancer therapy that contraindicates this study

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

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Edward C. Grendys, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Primary Completion

May 1, 2006

Last Updated

July 9, 2013

Record last verified: 2004-05