NCT00003951

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 DX-8951f in treating patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jun 1999

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 18, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

5.8 years

First QC Date

November 1, 1999

Last Update Submit

May 15, 2012

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancerduct cell adenocarcinoma of the pancreasstage IV pancreatic cancer

Interventions

exatecan mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas Metastatic disease Previously untreated disease or progressive disease after first-line chemotherapy Bidimensionally measurable disease Indicator lesion must be outside of any prior radiation port No brain metastases No islet cell tumors, lymphoma, or sarcoma of the pancreas PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No history of other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis, mental disability, or incompetence No other life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy No prophylactic colony stimulating factors to prevent neutropenia Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer treatment At least 28 days since other prior investigational drugs, including analgesics or antiemetics No other investigational drugs during and for 28 days after study No concurrent drugs that induce or inhibit CYP3A enzyme

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

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

exatecan

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert L. DeJager, MD, FACP

    Daiichi Sankyo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 18, 2004

Study Start

June 1, 1999

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

US(3)