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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00459836

PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors

A Phase 1 study testing PR-104, docetaxel and gemcitabine hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Proacta, Incorporated at 3 sites in 2 countries.

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, such as PR-104, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PR-104, docetaxel and gemcitabine hydrochloride
How many people
42 participants
Where
3 sitesin 2 countries
Study dates
Feb 2007to Oct 2009
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 confirmed solid tumor malignancy
  • Treatment with either docetaxel or gemcitabine hydrochloride in combination with an investigational agent is reasonable
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

  • ECOG performance status of 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL (red blood cell transfusion allowed)
  • Bilirubin normal
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN
  • PT/INR or aPTT ≤ 1.1 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study therapy
  • No evidence of any other significant medical disorder, including uncontrolled infection or infection requiring a concurrent parenteral antibiotic, or laboratory finding that, in the opinion of the investigator, would preclude study compliance
  • No known HIV positivity
  • No hepatitis B surface antigen positivity
  • No hepatitis C positivity with abnormal liver function test

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to > 25% of bone marrow
  • No prior high-dose chemotherapy (including conditioning for either myeloablative or nonmyeloablative transplantation)
  • No more than 3 prior chemotherapy regimens
  • More than 4 weeks since prior major surgery
  • More than 4 weeks since prior investigational or traditional anticancer therapy (including radiotherapy) (6 weeks for nitrosoureas and mitomycin C)
  • The following medications/treatments are not permitted during the trial:
  • Any other licensed or investigational anticancer treatment
  • Prophylactic hematopoietic growth factors
  • Irradiation therapy (palliative or therapeutic) unless given in the absence of tumor progression
  • Concurrent systemic steroids allowed provided the patient is on a stable dose for ≥ 2 weeks prior to study treatment
  • Concurrent androgen-deprivation therapy allowed

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

New Zealand2 sites

  • University of Auckland Cancer Center

    Auckland

  • Waikato Hospital

    Hamilton, 2020

Other trials in New Zealand

United States1 site

  • Proacta, Incorporated

    San Diego, California, 92121

Other trials in United States

About this study

Official title: A Phase Ib, Multi-Center, Open-Label, Dose Escalation Trial of Intravenous PR-104 Given in Combination With Docetaxel or Gemcitabine in Subjects With Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as PR-104, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with docetaxel or gemcitabine in treating patients with solid tumors.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of PR-104 in combination with docetaxel or gemcitabine hydrochloride in patients with solid tumors.

Secondary

  • Determine the safety of PR-104 in combination with docetaxel or gemcitabine hydrochloride in these patients.
  • Determine the antitumor activity of these regimens using disease-specific parameters, such as exams, scans, and tumor markers, in these patients.
  • Determine the pharmacokinetics of PR-104 and its alcohol metabolite in these patients.
  • Determine the pharmacokinetics of docetaxel and gemcitabine hydrochloride when administered with PR-104.
  • Collect plasma samples for assessment of potential biomarkers of tumor hypoxia from these patients.
  • Examine metabolic changes in tumors using fludeoxyglucose F 18 positron emission tomography (PET) and PET imaging with fluoromisonidazole F 18 (a hypoxia-targeted radiopharmaceutical) in these patients.

OUTLINE: This is a nonrandomized, open-label, uncontrolled, multicenter, dose-escalation study of PR-104. Patients are assigned to 1 of 2 treatment groups according to patient's malignancy and prior treatment history.

  • Group 1: Patients receive docetaxel IV over 60 minutes and PR-104 IV over 60 minutes on day 1.
  • Group 2: Patients receive gemcitabine hydrochloride IV over 30 minutes and PR-104 IV over 60 minutes on days 1 and 8.

In both groups, treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients in each group receive escalating doses of PR-104 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.

Blood is collected at baseline and periodically during course 1 for pharmacokinetic analysis. Plasma samples are analyzed for biomarkers of tumor hypoxia at baseline and on days 2 and 8.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Being tested
PR-104, docetaxel, gemcitabine hydrochloride, laboratory biomarker analysis, pharmacological study
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

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

What is being measured

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

  1. Maximum tolerated dose of PR-104

Secondary outcomes (5)

  1. Safety of PR-104 as measured by CTCAE v3.0 criteria

  2. Dose-limiting toxicity of PR-104

  3. Pharmacokinetics of PR-104 and its alcohol metabolite in the blood

  4. Pharmacokinetics of gemcitabine and docetaxel in the presence of PR-104

  5. Antitumor activity

Timeline

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

  1. First posted13 Apr 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionOct 2009

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459836
Sponsor's protocol ID
PR104-1003
Other IDs
PROACTA-PR-104-1003, PROACTA-WIRB-20070094
Status last verified
Feb 2011
First submitted
11 Apr 2007
Last updated
2 Mar 2011
Results posted
No

Publications

  • McKeage MJ, Jameson MB, Ramanathan RK, Rajendran J, Gu Y, Wilson WR, Melink TJ, Tchekmedyian NS. PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours. BMC Cancer. 2012 Oct 25;12:496. doi: 10.1186/1471-2407-12-496.

    PubMed 23098625

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PR-104, docetaxel and gemcitabine hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Proacta, Incorporated at 3 sites in 2 countries.

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 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in New Zealand, 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 of PR-104. 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 NCT00459836, 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 2 Mar 2011.

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