NCT00006486

Brief Summary

Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor

Trial Health

80
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for phase_2

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

October 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

July 28, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

5 years

First QC Date

November 6, 2000

Last Update Submit

January 15, 2013

Conditions

Recurrent Renal Cell CancerStage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (3)

  • Proportion of patients progressing on placebo to the proportion progressing on CAI

    Up to 16 weeks

  • Proportions of patients with stable disease

    Up to 16 weeks

  • Objective response

    Up to 16 weeks

Study Arms (2)

Arm I (carboxyaminoimidazole)

EXPERIMENTAL

Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive oral CAI as above.

Drug: carboxyamidotriazole

Arm II (carboxyamidotriazole, placebo)

EXPERIMENTAL

Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive a placebo.

Drug: carboxyamidotriazoleOther: placebo

Interventions

carboxyamidotriazoleDRUG

Given orally

Also known as: CAI, carboxyamido-triazole, carboxyaminoimidazole
Arm I (carboxyaminoimidazole)Arm II (carboxyamidotriazole, placebo)
placeboOTHER

Given orally

Also known as: PLCB
Arm II (carboxyamidotriazole, placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed renal cell carcinoma
  • Metastatic or unresectable disease
  • Documented disease progression, even after nephrectomy
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques
  • At least 10 mm by spiral CT scan
  • The following lesions are not considered measurable:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Abdominal masses not confirmed and followed by imaging
  • Cystic lesions
  • Performance status - CTC 0-2
  • WBC at least 2,000/mm\^3
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

carboxyamido-triazole

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Walter Stadler

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2000

First Posted

July 28, 2003

Study Start

October 1, 2000

Primary Completion

October 1, 2005

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)