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Lung CancerPhase 2NCT00022243

T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy

A Phase 2 study testing batabulin sodium in people with Lung Cancer, run by Tularik at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 T138067 in treating patients who have locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
batabulin sodium
How many people
Not given
Where
2 sitesUnited States
Study dates
Oct 2000to not given
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

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Locally advanced or metastatic disease Received a prior first-line taxane (as a single agent or component of a combination regimen) as the only chemotherapy for locally advanced or metastatic disease Any amount of prior adjuvant chemotherapy allowed Bidimensionally measurable disease outside the field of prior radiotherapy Amenable to radiologic imaging techniques No clinically apparent CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN Albumin greater than 2.5 g/dL No history of Gilbert's syndrome Renal: Creatinine no greater than 1.5 times ULN Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other severe disease, infection, or comorbidity that would preclude study participation No known defect of glutathione metabolism Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy or therapeutic biologic response modifiers No concurrent routine or prophylactic filgrastim (G-CSF) or sargramostim No concurrent epoetin alfa Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No other concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent hormonal therapy for NSCLC Radiotherapy: See Disease Characteristics At least 2 weeks since prior limited-field radiotherapy not involving the hematopoietic bone marrow and recovered At least 4 weeks since prior radiotherapy to no more than 25% of the hematopoietic bone marrow and recovered No prior wide-field radiotherapy to the pelvis No concurrent radiotherapy (including palliative radiotherapy) Surgery: At least 4 weeks since prior major surgery Other: At least 4 weeks since prior investigational agents No concurrent anticonvulsants unless required for study drug-related toxicity No concurrent high-dose acetaminophen (i.e., at least 4 g/day) No other concurrent investigational agents

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

Other trials in United States

About this study

Official title: A Phase II, Open Label Study Of T138067-Sodium In A Second-Line Setting In Non-Small-Cell Lung Cancer Patients With Locally Advanced Or Metastatic Disease Who Have Failed First-Line Therapy With a Taxane

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 T138067 in treating patients who have locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy.

Read the detailed description

OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic non-small cell lung cancer who have failed first-line therapy with a taxane when treated with T138067 sodium. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the number of patients who progress when treated with this drug. IV. Determine the duration of response, time to disease progression, and median survival of patients treated with this drug. V. Correlate the toxic effects of this drug with peak plasma levels in this patient population.

OUTLINE: This is a multicenter study. Patients receive T138067 sodium IV over 3 hours on days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months after study completion.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 9 months.

Conditions
Lung Cancer
Being tested
batabulin sodium
Keywords
recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • batabulin sodiumDrug

Timeline

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

  1. First posted4 Feb 2004 (estimated)
  2. Study startOct 2000

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 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022243
Sponsor's protocol ID
CDR0000068798
Other IDs
TULA-T2002, VU-000511
Status last verified
May 2002
First submitted
10 Aug 2001
Last updated
6 Jan 2014
Results posted
No

Publications

  • Jahan TM, Sandler A, Burris H, et al.: A phase II study of T138067-sodium in prior taxane-treated patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1282, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing batabulin sodium in people with Lung Cancer, run by Tularik 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: status not confirmed, as of the sponsor's last update on 6 Jan 2014. 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 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?

Results are not available in the source record.

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 NCT00022243, 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 6 Jan 2014.

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