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Pancreatic CancerPhase 1/2NCT00185588

Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

A Phase 1/2 study testing Vatalanib and Gemcitabine in people with Pancreatic Cancer, run by George Albert Fisher 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

The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Vatalanib and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
Oct 2004to Dec 2009
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 adenocarcinoma of the pancreas
  • Unresectable (due to involvement of critical vasculature, adjacent organ invasion, or presence of metastasis)
  • If > 5 years between the primary surgery and the development of metastatic disease, then separate histological or cytological confirmation of metastatic disease
  • Primary or metastatic lesion within 4 weeks prior to entry of study
  • WHO performance status of 0 to 2
  • ≤ 18 years of age
Show all 19Show fewer
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10e9/L (>= 1500/mm3)
  • Platelets (PLT) ≥ 100 x 10^9/L (≥ 100,000/mm3)
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Serum creatinine ≤ 1.5 upper limit of normal (ULN)
  • Serum bilirubin ≤ 1.5 ULN
  • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase
  • (ALT/SGPT) ≤ 3.0 x ULN OR
  • ≤ 5 x ULN if liver metastases present
  • Proteinuria:
  • Negative for proteinuria based on dip stick reading OR
  • If dip stick reading is +1 result, then total urinary protein ≤ 500 mg and measured creatinine clearance (CrCl) ≥ 50 mL/min from a 24-hour urine collection
  • Life expectancy ≥ 12 weeks
  • Ability to give written informed consent

Who cannot join

  • For the "phase 1" portion of the study: prior gemcitabine will be therapy.
  • For the "phase 2" portion of the study: any prior chemotherapy {except for low-dose 5-fluorouracil (5-FU)as a radiosensitizer]
  • Radiotherapy (RT). The site of previous RT must have progressive disease if the only site of disease).
  • Prior full field radiotherapy ≤ 4 weeks prior to enrollment OR
  • Limited field radiotherapy ≤ 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities.
  • Prior biologic or immunotherapy ≤ 2 weeks prior to registration.
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  • Prior therapy with anti-VEGF agents
  • History or presence of central nervous system (CNS) disease
  • Patients with a history of another primary malignancy ≤ 5 years (Exception: inactive basal or squamous cell carcinoma of the skin)
  • Major surgery ≤ 4 weeks prior to enrollment. (Exception: insertion of a vascular access device)
  • Minor surgery ≤ 2 weeks prior to enrollment. (Exception: insertion of a vascular access device)
  • Concurrent use of other investigational agents and patients who have received investigational drugs ≤ 4 weeks prior to enrollment.
  • Pregnant, or breast-feeding, not employing an effective method of birth control.
  • Pre-existing peripheral sensory neuropathy with functional impairment (≥ CTCAE grade 2 neuropathy)
  • Respiratory compromise due to pleural effusion or ascites (≥ CTCAE grade 2 dyspnea)
  • QTc > 450 ms (male) or > 470 ms (female)
  • Uncontrolled high blood pressure
  • History of labile hypertension
  • History of poor compliance with an antihypertensive regimen
  • Unstable angina pectoris
  • Symptomatic congestive heart failure
  • Myocardial infarction ≤ 6 months prior to registration / randomization
  • Serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes
  • Active or uncontrolled infection
  • Interstitial pneumonia
  • Extensive and symptomatic interstitial fibrosis of the lung
  • Chronic renal disease
  • Acute or chronic liver disease
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib
  • Human immunodeficiency virus (HIV) infection (confirmed), if there is potential for interaction between vatalanib and any anti-HIV medication
  • HIV infection (confirmed) judged to increase subject risk due to the pharmacologic activity of vatalanib
  • Receiving warfarin sodium (Coumadin) or similar. Heparin is allowed.
  • Unwilling to or unable to comply with

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase 1-2 Study of the VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 <Vatalanib> and Gemcitabine in Patients With Advanced Pancreatic Cancer

The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.

Being tested
Vatalanib, Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • VatalanibDrug

    Also called PTK787, ZK 222584, PTK787/ZK 222584

    Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours

  • GemcitabineDrug

    Also called Gemzar

    850 mg/m2

Study groups in NCT00185588
Study groupRoleWhat they receive
Stage 1 Dose Exploration 0 - Gemcitabine 700 + vatalanib 1250ExperimentalGemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Receives: Drug: Vatalanib; Drug: Gemcitabine
Stage 1 Dose Exploration 1 - Gemcitabine 850 + vatalanib 1250ExperimentalGemcitabine 850 mg/m2 + vatalanib 1250 mg
Receives: Drug: Vatalanib; Drug: Gemcitabine
Stage 1 Dose Explrtion2 - Gemcitabine850+vatalanib 2x250/2x500ExperimentalGemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Receives: Drug: Vatalanib; Drug: Gemcitabine
Stage 2 Dose Expansion - Gemcitabine850+vatalanib 2x250/2x500ExperimentalGemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Receives: Drug: Vatalanib; Drug: Gemcitabine

What is being measured

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

  1. Time-to-Treatment Failure (Intent-To-Treat Analysis)

    For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.

    Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

    Measured: 12 months

Secondary outcomes (1)

  1. Time-to-Progression, Evaluable Patients

    Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.

    Measured: 12 months

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionJan 2009
  4. Study completionDec 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00185588
Sponsor's protocol ID
IRB-06999
Other IDs
95533, CPTK787AUS08, PANC0002
Status last verified
Sep 2014
First submitted
12 Sep 2005
Last updated
15 Sep 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vatalanib and Gemcitabine in people with Pancreatic Cancer, run by George Albert Fisher at 1 site 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?

The sponsor lists 19 inclusion and 34 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 15 Sep 2014. 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 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?

Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time-to-Treatment Failure (Intent-To-Treat Analysis) (time frame: 12 months). 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 NCT00185588.

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 Sep 2014.

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