NCT00003548

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 trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

February 20, 2004

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

3.3 years

First QC Date

May 2, 2000

Last Update Submit

March 25, 2011

Conditions

Cancer

Keywords

stage IV colon cancerstage IV breast cancerrecurrent breast cancerstage IV gastric cancerrecurrent gastric cancerrecurrent pancreatic cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage IV anal cancerrecurrent anal cancerstage IV esophageal cancerrecurrent esophageal cancerstage IV cervical cancerrecurrent cervical cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerstage IV vulvar cancerrecurrent vulvar cancerstage IVA vaginal cancerstage IVB vaginal cancerrecurrent vaginal cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumoradvanced adult primary liver cancerrecurrent adult primary liver cancerrecurrent gestational trophoblastic tumorstage IV endometrial carcinomarecurrent endometrial carcinomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancercarcinoma of the appendixfallopian tube cancerstage IV uterine sarcomarecurrent uterine sarcomarecurrent carcinoma of unknown primarystage IV pancreatic cancer

Interventions

aminocamptothecin colloidal dispersionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed advanced malignancy involving the peritoneal cavity, excluding leukemia and lymphoma Patients with ovarian cancer must have received prior standard therapy Predominantly small tumor metastases less than 1.0 cm in diameter including: Ovarian cancer with epithelial histology Other gynecological tumors Breast cancer Gastric cancer Colorectal cancer Appendiceal cancer Pancreatic cancer Unknown primary cancer Other malignancies with predominantly intraperitoneal manifestation No extensive intraperitoneal adhesions that cannot be easily lysed laparoscopically or by laparotomy No symptomatic disease outside the peritoneal cavity Asymptomatic disease outside the peritoneum considered (e.g., bone lesions) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and/or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsBreast NeoplasmsStomach NeoplasmsPancreatic NeoplasmsRectal NeoplasmsAnus NeoplasmsEsophageal NeoplasmsUterine Cervical NeoplasmsCarcinoma, Ovarian EpithelialVulvar NeoplasmsVaginal NeoplasmsCarcinoma, HepatocellularGestational Trophoblastic DiseaseEndometrial NeoplasmsGallbladder NeoplasmsBile Duct NeoplasmsAppendiceal NeoplasmsFallopian Tube NeoplasmsNeoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesAnus DiseasesHead and Neck NeoplasmsEsophageal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersVulvar DiseasesVaginal DiseasesAdenocarcinomaLiver NeoplasmsLiver DiseasesTrophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalPregnancy Complications, NeoplasticPregnancy ComplicationsBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesCecal NeoplasmsCecal DiseasesFallopian Tube DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Franco M. Muggia, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

February 20, 2004

Study Start

August 1, 1998

Primary Completion

December 1, 2001

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

US(1)