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Recurrent Non-small Cell Lung CancerPhase 1/2NCT00074022

GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors

A Phase 1/2 study testing GTI-2040, docetaxel and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in Canada.

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

Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prostate cancer, or other solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GTI-2040, docetaxel and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteCanada
Study dates
Oct 2003to Nov 2007
Phase
Phase 1/2
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 or cytologically confirmed diagnosis of 1 of the following:
  • Solid tumor malignancy (phase I only)*
  • Prostate cancer (phase I only)*
  • Non-small cell lung cancer (phase I and II)*
  • Recurrent, metastatic, locally advanced unresectable, or treatment-refractory disease
  • Measurable disease
Show all 56Show fewer
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Previously irradiated lesions are considered measurable provided they have demonstrated progression before study entry
  • No bone-only disease
  • Must have measurable disease other than bone lesions
  • No stage IIIA or IIIB non-small cell lung cancer without a malignant pleural or pericardial effusion that is eligible for first-line radical combined chemotherapy and radiotherapy
  • No known progressive or symptomatic brain metastases
  • Asymptomatic brain metastases allowed
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No history of coagulopathy
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2 times ULN (3.5 times ULN if liver metastases are present)
  • INR no greater than 1.3
  • APTT no greater than 1.25 times ULN
  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min
  • No symptomatic congestive heart failure
  • No evidence of cardiac dysfunction
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active peptic ulcer disease
  • No poorly controlled diabetes mellitus
  • No pre-existing grade 2 or greater neuropathy
  • No ongoing or active infection
  • No contraindication to corticosteroids
  • No psychiatric illness or social situation that would limit compliance with study requirements
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No other concurrent uncontrolled illness
  • One, and only one, prior chemotherapy regimen for advanced disease (not including adjuvant therapy) allowed
  • Neoadjuvant/adjuvant chemotherapy allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
  • Prior multiple lines of endocrine therapy for advanced solid tumors allowed
  • More than 4 weeks since prior endocrine therapy and recovered
  • Concurrent steroids allowed
  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to sole site of measurable disease
  • Prior surgery allowed
  • No concurrent anticoagulant therapy
  • Concurrent low-dose warfarin for central line thrombosis prophylaxis allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies intended to treat the malignancy
  • Concurrent bisphosphonates allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital Phase 2 Consortium

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase I/2 Study of GTI-2040 Combined With Docetaxel In Metastatic Or Unresectable Locally Advanced Non-Small Cell Lung Cancer

Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prostate cancer, or other solid tumors. GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. Combining GTI-2040 with docetaxel may kill more tumor cells

Read the detailed description

OBJECTIVES:

  1. Determine the recommended phase II dose of GTI-2040 and docetaxel in patients with recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prostate cancer, or other solid tumors (phase I study closed to accrual as of 8/5/2004).

II. Determine the toxicity of this regimen in these patients. III. Determine the objective tumor response rate in patients treated with this regimen.

IV. Determine the stable disease rate, time to disease progression, objective response duration, and duration of stable disease in patients treated with this regimen.

  1. Determine the pharmacokinetics of GTI-2040 when administered in combination with docetaxel in these patients.

VI. Correlate the pharmacokinetics of GTI-2040 with the biological and toxic effects of this regimen in these patients.

VII. Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc, ras, pRAF1, pMAPK, and markers of apoptosis with clinical outcome in patients treated with this regimen.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Phase I (closed to accrual as of 8/5/2004): Patients receive GTI-2040 IV continuously on days 1-14. Patients also receive docetaxel IV over 1 hour on day 3 during course 1 and on day 1 for all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of GTI-2040 and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RP2D) is defined as the dose preceding the MTD.

Phase II: Patients receive GTI-2040 and docetaxel at the RP2D as in phase I.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-48 patients (12-18 for phase I [closed to accrual as of 8/5/2004] and 15-30 for phase II) will be accrued for this study within 4-16 months.

Being tested
GTI-2040, docetaxel, laboratory biomarker analysis, pharmacological study
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms

What participants receive

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

  • GTI-2040Biological

    Given IV

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00074022
Study groupRoleWhat they receive
Treatment (GTI-2040, docetaxel)ExperimentalPhase I (closed to accrual as of 8/5/2004): Patients receive GTI-2040 IV continuously on days 1-14. Patients also receive docetaxel IV over 1 hour on day 3 during course 1 and on day 1 for all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GTI-2040 and docetaxel until the MTD is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The RP2D is defined as the dose preceding the MTD. Phase II: Patients receive GTI-2040 and docetaxel at the RP2D as in phase I.
Receives: Biological: GTI-2040; Drug: docetaxel; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients experiencing dose limiting toxicities (DLTs), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 (Phase I)

    Measured: Up to day 21

  2. Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)

    The 95% confidence intervals will be provided.

    Measured: Up to day 42

Secondary outcomes (7)

  1. Stable disease rate

    Measured: Up to 6 weeks

  2. Response duration

    The 95% confidence intervals will be provided.

    Measured: Up to 4 years

  3. Toxicities of GTI-2040 combined with docetaxel, graded according to the NCI CTC v2.0

    Measured: Up to 4 years

  4. Time to disease progression

    Measured: Up to 4 years

  5. Duration of stable disease

    Measured: Up to 6 weeks

  6. Level of ribonucleotide reductase (RNR) activity

    Logistic regression and descriptive statistics will be used.

    Measured: Up to week 10

  7. Tumoral expression in terms of c-myc, R2 subunit protein levels and markers of proliferation (cyclin B1) and apoptosis (activated caspase 3)

    Logistic regression and descriptive statistics will be used.

    Measured: Up to week 10

Timeline

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

  1. First posted11 Dec 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionNov 2007

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00074022
Sponsor's protocol ID
NCI-2012-02563
Other IDs
PMH-PHL-017, N01CM17107, CDR0000341677
Status last verified
Jan 2013
First submitted
10 Dec 2003
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GTI-2040, docetaxel and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in Canada.

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 56 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 24 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 Canada. 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 combined 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.

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?

Number of patients experiencing dose limiting toxicities (DLTs), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 (Phase I) (time frame: Up to day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00074022.

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 24 Jan 2013.

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