NCT00003760

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 irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Nov 1998

Shorter than P25 for phase_2 pancreatic-cancer

Geographic Reach
1 country

3 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

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

August 4, 2004

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

November 1, 1999

Last Update Submit

August 7, 2012

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancerstage IV pancreatic cancerrecurrent pancreatic canceradenocarcinoma of the pancreas

Interventions

irofulvenDRUG

Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for up to 1 year after therapy initiation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV unresectable adenocarcinoma of the exocrine pancreas Must have been treated with 1 prior gemcitabine regimen, and have documented disease progression either during or within 6 months after completion of therapy Measurable or evaluable disease outside of previously irradiated area No islet cell tumors or lymphoma of the pancreas No significant CNS disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No atrial or ventricular arrhythmias requiring medication No atrial fibrillation (with or without medication) No ischemic event within past 6 months No history of congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No significant psychiatric disorders No active infection No other prior malignancies within past 5 years, except: Basal or squamous cell skin cancer Carcinoma in situ of the cervix No concurrent serious systemic disorder PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior gemcitabine therapy and recovered No other prior chemotherapy (except fluorouracil as a radiation enhancing agent) No other concurrent chemotherapy Endocrine therapy: No prior hormonal therapy No concurrent hormonal therapy (except contraceptives, hormone replacement, or megestrol acetate) Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational agents

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

Sponsors & Collaborators

Study Sites (3)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

San Antonio Cancer Institute

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irofulven

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Eric K. Rowinsky, MD

    San Antonio Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 4, 2004

Study Start

November 1, 1998

Primary Completion

May 1, 2000

Study Completion

May 1, 2000

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

US(3)