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Brain and Central Nervous System TumorsPhase 1NCT00019019

Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas

A Phase 1 study testing carboxyamidotriazole and paclitaxel in people with Brain and Central Nervous System Tumors and Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carboxyamidotriazole and paclitaxel
How many people
70 participants
Where
2 sitesUnited States
Study dates
Oct 1994to Jul 2006
Phase
Phase 1
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

DISEASE CHARACTERISTICS:

  • Histologically diagnosed solid tumor (i.e., breast and ovarian epithelial carcinomas) or lymphoma
  • Slides reviewed at the NCI Laboratory of Pathology
  • Failure on therapy of proven efficacy for the disease
  • Prior therapy not required for the following metastatic diseases:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • No brain metastases
  • Primary brain tumors (such as glioblastoma multiforme) with stable neurologic deficits allowed
  • Measurable or evaluable disease required
  • Demonstrated by physical exam or on radiograph within 2 weeks prior to initiation of treatment OR
  • Elevated PSA associated with prostate cancer
  • Other marker-only disease ineligible

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hematocrit at least 27%

Hepatic:

  • Liver function tests no greater than 2 times upper limit of normal
  • Bilirubin normal
  • PT or PTT no greater than 1.25 times upper limit of normal
  • Clotting parameters normal
  • No concurrent anticoagulants other than 1 mg of warfarin per day for prophylaxis

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 45 mL/min
  • No kidney obstruction

Cardiovascular:

  • No cardiac conduction defect requiring antiarrhythmics
  • No evidence of myocardial infarction or other myocardial damage within past 6 months

Other:

  • HIV negative
  • No concurrent infection
  • No guaiac-positive stool test
  • No neuropathy greater than grade I (unless associated with fixed-deficit primary brain tumors)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

  • Recovery from prior therapy required

Biologic therapy:

  • At least 4 weeks since prior biologic therapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks since mitomycin, nitrosoureas, or carboplatin)
  • No progression on carboxyamidotriazole or paclitaxel
  • At least 6 months between treatment and relapse

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • No concurrent corticosteroids except as physiologic replacement

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified

Other:

  • At least 1 week since prior therapeutic antibiotics
  • Concurrent prophylactic antibiotics allowed except imidazole antifungals (e.g., ketoconazole, fluconazole)
  • No concurrent calcium channel blockers

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • NCI - Medical Oncology Clinical Research Unit

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of paclitaxel when combined with carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas.
  • Determine the pharmacokinetics and toxicities of this regimen in these patients.
  • Identify diseases for which this combination appears active.

OUTLINE: This is a dose escalation study.

Patients receive oral carboxyamidotriazole (CAI) daily with paclitaxel IV over 3 hours on day 8 and every 3 weeks thereafter. Course 1 is 28 days and all other subsequent courses are 21 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses of treatment.

Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel. Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Being tested
carboxyamidotriazole, paclitaxel
Keywords
stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, recurrent non-small cell lung cancer, recurrent adult Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, recurrent adult brain tumor, small intestine lymphoma, adult brain stem glioma
Medical subject headings
Central Nervous System Neoplasms, Breast Neoplasms, Kidney Neoplasms, Lung Neoplasms, Lymphoma, Melanoma, Ovarian Neoplasms, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 1994
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

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 1
Primary purpose
Treatment
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019019
Sponsor's protocol ID
950015
Other IDs
95-C-0015, NCI-CPB-334, NCI-T94-0006N, CDR0000063881
Status last verified
Mar 2012
First submitted
11 Jul 2001
Last updated
15 Mar 2012
Results posted
No

Publications

  • Kohn EC, Reed E, Sarosy GA, Minasian L, Bauer KS, Bostick-Bruton F, Kulpa V, Fuse E, Tompkins A, Noone M, Goldspiel B, Pluda J, Figg WD, Liotta LA. A phase I trial of carboxyamido-triazole and paclitaxel for relapsed solid tumors: potential efficacy of the combination and demonstration of pharmacokinetic interaction. Clin Cancer Res. 2001 Jun;7(6):1600-9.

    PubMed 11410496

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing carboxyamidotriazole and paclitaxel in people with Brain and Central Nervous System Tumors and Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites 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?

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 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00019019, which also lists 1 linked publication.

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 15 Mar 2012.

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