NCT00003677

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 dolastatin 10 in treating patients who have metastatic pancreatic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Feb 1999

Geographic Reach
1 country

2 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

February 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2002

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

July 22, 2004

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

November 1, 1999

Last Update Submit

October 23, 2018

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic canceradenocarcinoma of the pancreasstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Toxicity

    Toxic effects of dolastatin 10 therapy in patients with metastatic adenocarcinoma of the pancreas used to assess antitumor activity.

    Every 3 months

Study Arms (1)

Dolastatin 10

EXPERIMENTAL

Dolastatin 10 IV bolus once every 21 days.

Drug: Dolastatin 10

Interventions

Dolastatin 10DRUG

IV bolus once every 21 days.

Dolastatin 10

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the pancreas Bidimensionally measurable lesions with sentinel lesions outside field of any prior radiation therapy No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina At least 6 months since prior myocardial infarction No uncontrolled hypertension Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent serious infection At least 5 years since prior malignancy except the following: Nonmelanoma skin cancer Carcinoma in situ of the cervix No overt psychosis or mental disability PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 6 months since prior adjuvant chemoradiation to disease At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: At least 4 weeks since prior investigational drug (including analgesics or antiemetics) No other concurrent anticancer therapy

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

Sponsors & Collaborators

Study Sites (2)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

dolastatin 10

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hedy L. Kindler, MD

    University of Chicago

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 22, 2004

Study Start

February 1, 1999

Primary Completion

January 16, 2002

Study Completion

January 16, 2002

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(2)