Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00078962

GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

A Phase 1 study testing GTI-2040, gemcitabine hydrochloride and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site 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

This phase I trial is studying the side effects and best dose of GTI-2040 and gemcitabine in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: GTI-2040, gemcitabine hydrochloride and laboratory biomarker analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jan 2004to Nov 2007
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

Who may be able to join

Histologically or cytologically confirmed solid tumor
Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective
Measurable or evaluable disease
No known active or progressive brain metastases or primary brain tumors
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%

Show all 43Show fewer

More than 12 weeks
Hemoglobin > 9 g/dL
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
Creatinine ≤ 2.0 mg/dL
Creatinine clearance ≥ 50 mL/min
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No other condition (e.g., dementia or developmental delay) that would preclude giving informed consent
No other concurrent uncontrolled illness that would preclude study participation
Prior biologic therapy allowed
No concurrent biologic therapy
No concurrent immunotherapy
No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)
Prior gemcitabine allowed
Prior investigational chemotherapy allowed
At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, carmustine, or nitrosoureas) and recovered
No other concurrent chemotherapy
Concurrent hormonal therapy (e.g., luteinizing hormone-releasing hormone agonists) for prostate cancer is allowed
At least 4 weeks since prior radiotherapy and recovered
No prior radiotherapy to more than 25% of bone marrow
No concurrent radiotherapy
Recovered from prior surgery
No other concurrent investigational therapy
No other concurrent anticancer therapy
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent long-term oral anticoagulation therapy (e.g., warfarin)
Prophylactic warfarin to maintain central venous access patency allowed

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors

Read the detailed description

OBJECTIVES: Primary I. Determine the toxicity profile and maximum tolerated dose of GTI-2040 and gemcitabine in patients with metastatic or unresectable solid tumors.

Secondary I. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.

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

Patients receive GTI-2040 IV continuously on days 2-16 of course 1 and on days 1-16 of all subsequent courses and gemcitabine IV over 30 minutes on days 1, 8, and 15 of course 1 and on days 2, 9, and 16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of GTI-2040 and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose.

PROJECTED ACCRUAL: Approximately 18-40 patients will be accrued for this study within 6-20 months.

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Being tested: GTI-2040, gemcitabine hydrochloride, laboratory biomarker analysis, pharmacological study

What participants receive

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

GTI-2040Biological
Given IV
gemcitabine hydrochlorideDrug
Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Given IV
laboratory biomarker analysisOther
Correlative studies
pharmacological studyOther
Also called pharmacological studies
Correlative studies

Study groups in NCT00078962
Study group	Role	What they receive
Treatment (GTI-2040, gemcitabine hydrochloride)	Experimental	Patients receive GTI-2040 IV continuously on days 2-16 of course 1 and on days 1-16 of all subsequent courses and gemcitabine IV over 30 minutes on days 1, 8, and 15 of course 1 and on days 2, 9, and 16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GTI-2040 and gemcitabine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose. Receives: Biological: GTI-2040; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

Maximum tolerated dose (MTD) of GTI-2040 and gemcitabine hydrochloride, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0
Measured: Up to day 28
Adverse events, graded according to the NCI CTC v3.0
Measured: Up to 2 years

Secondary outcomes (3)

Levels of gemcitabine triphosphate (dFdCTP) in terms of pharmacokinetics of gemcitabine hydrochloride
Measured: Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)
Levels of ribonucleotide reductase R2 and protein expression
Student t-tests will be employed.
Measured: Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)
Levels of apoptotic markers and cell cycle regulatory proteins
Student t-tests will be employed.
Measured: Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)

Timeline

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

Jan 2004Nov 2007

First posted9 Mar 2004 (estimated)
Study startJan 2004
Primary completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00078962
Sponsor's protocol ID: NCI-2012-02577
Other IDs: 03-06, U01CA069853, CDR0000353204
Status last verified: Jan 2013
First submitted: 8 Mar 2004
Last updated: 24 Jan 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
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3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
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All Unspecified Adult Solid Tumor, Protocol Specific trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Pharmacokinetics and Pharmacodynamic Study of GTI2040 in Combination With Gemcitabine in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT00078962
Acronym / sponsor ID: NCI-2012-02577
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Jan 2004
Primary completion: Nov 2007 (actual)
First posted: 9 Mar 2004 (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.

Detailed description

OBJECTIVES: Primary I. Determine the toxicity profile and maximum tolerated dose of GTI-2040 and gemcitabine in patients with metastatic or unresectable solid tumors.

Secondary I. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.

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

PROJECTED ACCRUAL: Approximately 18-40 patients will be accrued for this study within 6-20 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (GTI-2040, gemcitabine hydrochloride)	Experimental	Biological: GTI-2040, Drug: gemcitabine hydrochloride, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive GTI-2040 IV continuously on days 2-16 of course 1 and on days 1-16 of all subsequent courses and gemcitabine IV over 30 minutes on days 1, 8, and 15 of course 1 and on days 2, 9, and 16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GTI-2040 and gemcitabine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (43 listed)

Histologically or cytologically confirmed solid tumor
Measurable or evaluable disease
No known active or progressive brain metastases or primary brain tumors
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%

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
GTI-2040Given IV	Biological	Treatment (GTI-2040, gemcitabine hydrochloride)
gemcitabine hydrochlorideAlso: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, GemzarGiven IV	Drug	Treatment (GTI-2040, gemcitabine hydrochloride)
laboratory biomarker analysisCorrelative studies	Other	Treatment (GTI-2040, gemcitabine hydrochloride)
pharmacological studyAlso: pharmacological studiesCorrelative studies	Other	Treatment (GTI-2040, gemcitabine hydrochloride)

Primary outcome

Maximum tolerated dose (MTD) of GTI-2040 and gemcitabine hydrochloride, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0
Time frame: Up to day 28
Adverse events, graded according to the NCI CTC v3.0
Time frame: Up to 2 years

3 secondary outcomes

Levels of gemcitabine triphosphate (dFdCTP) in terms of pharmacokinetics of gemcitabine hydrochloride
Time frame: Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)
Levels of ribonucleotide reductase R2 and protein expression
Time frame: Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)
Levels of apoptotic markers and cell cycle regulatory proteins
Time frame: Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)

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 24 Jan 2013.

Related trials for Unspecified Adult Solid Tumor, Protocol Specific

Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
Recruiting
Copenhagen Prospective Personalized Oncology (CoPPO)
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders

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.

Chris Takimoto principal investigator

Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 43 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 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.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of GTI-2040 and gemcitabine hydrochloride, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0 (time frame: Up to day 28). 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 NCT00078962.

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.