NCT00017017

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_1

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

February 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 13, 2003

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 30, 2013

Status Verified

December 1, 2009

Enrollment Period

2 years

First QC Date

June 6, 2001

Last Update Submit

May 29, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

paclitaxel poliglumexDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma * Recurrent disease following prior initial therapy with platinum-based regimen * No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease * No more than 1 prior non-platinum, non-taxane regimen * At least 1 site of radiographically measurable disease AND/OR * CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples PATIENT CHARACTERISTICS: Age * Not specified Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT less than 1.5 times ULN * Alkaline phosphatase less than 1.5 times ULN Renal * Creatinine no greater than 1.5 mg/dL Other * No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs * No active uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy and recovered Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy * At least 4 weeks since prior endocrine therapy and recovered Radiotherapy * At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered Surgery * Not specified Other * At least 4 weeks since other prior investigational drugs and recovered

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

paclitaxel poliglumex

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

Study Officials

  • Paul Sabbatini, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2001

First Posted

November 13, 2003

Study Start

February 1, 2001

Primary Completion

February 1, 2003

Study Completion

December 1, 2009

Last Updated

May 30, 2013

Record last verified: 2009-12

Locations

US(1)