Recurrent Renal Cell CancerPhase 2NCT00006486
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing carboxyamidotriazole in people with Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
- What is being tested?
- carboxyamidotriazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 33Show fewer
- 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
- Platelet count at least 75,000/mm^3
- Bilirubin no greater than upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
- Creatinine no greater than 2.0 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No baseline neuropathy or cerebellar dysfunction greater than grade 1
- At least 4 weeks since prior immunotherapy
- No prior carboxyamidotriazole
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- Concurrent epoetin alfa allowed
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes)
- At least 4 weeks since prior radiotherapy
- No concurrent palliative radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma
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
Read the detailed description
OBJECTIVES:
- Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.
II. Determine the objective response rate in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more).
Patients receive oral carboxyamidotriazole (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 with stable disease are randomized to one of two treatment arms.
Arm I: Patients receive oral CAI as above.
Arm II: Patients receive a placebo.
Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.
- Being tested
- carboxyamidotriazole, placebo
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboxyamidotriazoleDrug
Also called CAI, carboxyamido-triazole, carboxyaminoimidazole
Given orally
placeboOther
Also called PLCB
Given orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: carboxyamidotriazole; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients progressing on placebo to the proportion progressing on CAI
Measured: Up to 16 weeks
Proportions of patients with stable disease
Measured: Up to 16 weeks
Objective response
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2003 (estimated)
- Study startOct 2000
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Walter Stadler, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006486
- Sponsor's protocol ID
- NCI-2012-02364
- Other IDs
- CLB-69901, U10CA031946, CDR0000068317
- Status last verified
- Jan 2013
- First submitted
- 6 Nov 2000
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma
- ClinicalTrials.gov ID
- NCT00006486
- Acronym / sponsor ID
- NCI-2012-02364
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2000
- Primary completion
- Oct 2005 (actual)
- First posted
- 28 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OBJECTIVES:
- Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.
II. Determine the objective response rate in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more).
Patients receive oral carboxyamidotriazole (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 with stable disease are randomized to one of two treatment arms.
Arm I: Patients receive oral CAI as above.
Arm II: Patients receive a placebo.
Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (carboxyaminoimidazole) | Experimental | Drug: carboxyamidotriazolePatients 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. |
| Arm II (carboxyamidotriazole, placebo) | Experimental | Drug: carboxyamidotriazole, Other: placeboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Histologically confirmed renal cell carcinoma
- At least 1 unidimensionally measurable lesion
- Performance status - CTC 0-2
- WBC at least 2,000/mm^3
- Platelet count at least 75,000/mm^3
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboxyamidotriazoleAlso: CAI, carboxyamido-triazole, carboxyaminoimidazoleGiven orally | Drug | Arm I (carboxyaminoimidazole), Arm II (carboxyamidotriazole, placebo) |
| placeboAlso: PLCBGiven orally | Other | Arm II (carboxyamidotriazole, placebo) |
Primary outcome
Proportion of patients progressing on placebo to the proportion progressing on CAI
Time frame: Up to 16 weeks
Proportions of patients with stable disease
Time frame: Up to 16 weeks
Objective response
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Stadler principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboxyamidotriazole in people with Recurrent Renal Cell Cancer and Stage IV Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients progressing on placebo to the proportion progressing on CAI (time frame: Up to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.