NCT00005981

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Jun 2000

Typical duration for phase_2 colorectal-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

June 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

3.4 years

First QC Date

July 5, 2000

Last Update Submit

June 9, 2010

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.

    Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.

Interventions

O6-benzylguanineDRUG

Patients receive O6-benzylguanine (BG) IV over 1 hour. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.

carmustineDRUG

Carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of metastatic colorectal carcinoma * Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 4,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 8 g/dL Hepatic: * Bilirubin no greater than 1.2 mg/dL * AST and ALT less than 2.5 times upper limit of normal (ULN) * PT no greater than ULN (not on anticoagulation therapy) Renal: * Creatinine no greater than 1.5 mg/dL * Creatine clearance greater than 60 mL/min Pulmonary: * DLCO at least 60% Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study * No other concurrent active malignancies * Prior malignancies presumed to be cured allowed * No other concurrent uncontrolled severe medical problem that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 6 months since prior adjuvant chemotherapy without disease recurrence * No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy: * Not specified Radiotherapy: * Prior adjuvant radiotherapy allowed * No prior radiotherapy to more than 25% of total bone marrow Surgery: * Not specified Other: * No other prior therapy for advanced disease

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

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

O(6)-benzylguanineCarmustine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Study Officials

  • Smitha Krishnamurthi, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

June 1, 2000

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(1)