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LeukemiaPhase 2NCT00072475

Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

A Phase 2 study testing vatalanib in people with Leukemia and Myelodysplastic Syndromes, run by Alliance for Clinical Trials in Oncology at 68 sites 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

RATIONALE: Vatalanib may be effective in preventing the development of leukemia in patients who have myelodysplastic syndromes. PURPOSE: This phase II trial is studying vatalanib to see how well it works in treating patients with primary or secondary myelodysplastic syndromes. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vatalanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
68 sitesUnited States
Study dates
Dec 2003to Jun 2014
Phase
Phase 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

DISEASE CHARACTERISTICS:

  • Diagnosis of primary or secondary (therapy-related) myelodysplastic syndromes* (MDS), including the following cellular types:
  • Refractory anemia (RA)**
  • RA with excess blasts (RAEB)-1
  • RA with ringed sideroblasts**
  • Refractory cytopenia with multilineage dysplasia
  • Refractory cytopenia with multilineage dysplasia with ringed sideroblasts*
  • MDS-unclassified**
  • MDS associated with isolated del (5q)**
  • Chronic myelomonocytic leukemia (CMML)-1 NOTE: *High-risk MDS (i.e., RAEB-2 or CMML-2) is closed to accrual as of 11/30/06

NOTE: **Accompanied with at least 1 of the following laboratory values: hemoglobin less than 10 g/dL, platelet count less than 50,000/mm3, or absolute neutrophil count less than 1,000/mm3

  • No prior leukemia (i.e., 20% or greater blasts)
  • No prior primary or metastatic brain tumor or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • APTT no greater than 1.5 times ULN
  • INR no greater than 1.5

Renal

  • Creatinine no greater than 1.5 times ULN
  • Urine protein negative by urinalysis
  • Protein 1+ by dipstick allowed provided total urine protein no greater than 500 mg AND creatinine clearance at least 50 mL/min by 24-hour urine collection

Cardiovascular

  • No significant cardiac or vascular events within the past 6 months, including any of the following:
  • Acute myocardial infarction
  • Unstable angina
  • Uncontrolled hypertension
  • Severe peripheral vascular disease (e.g., ischemic pain at rest or nonhealing ulcers or wounds)
  • New York Heart Association class II-IV congestive heart failure
  • Cardiac arrhythmia
  • Disseminated intravascular coagulation or other coagulopathies
  • Deep vein or arterial thrombosis
  • No history of congenital long QTc syndrome or elongated QTc (> 450 msec for males or 470 for females)

Pulmonary

  • No pulmonary embolism within the past 6 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
  • No need for full anticoagulation within the past 6 months
  • No significant hemorrhage (e.g., visceral, gastrointestinal, genitourinary, or gynecological) requiring red blood cell transfusion within the past month
  • No known cerebral aneurysms, other cerebrovascular malformations, or CNS bleeding
  • No unhealed fractures, wounds, or ulcers

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 12 months since prior autologous stem cell or allogeneic transplantation
  • More than 6 months since prior antiangiogenic agents
  • More than 1 month since prior interferon for MDS
  • More than 1 month since prior hematopoietic growth factors for MDS
  • More than 1 month since prior epoetin alfa (EPO) for MDS
  • More than 1 month since prior thalidomide for MDS
  • More than 1 month since prior immunotherapy for MDS
  • No concurrent prophylactic growth factors or cytokines (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], EPO or EPO-derivatives, or interleukin-11)

Chemotherapy

  • No prior low-dose antimetabolites for MDS (e.g., hydroxyurea, azacitidine, or low-dose cytarabine)
  • More than 12 months since prior chemotherapy for another disease* NOTE: *Not MDS or leukemia

Endocrine therapy

  • More than 1 month since prior corticosteroids for MDS
  • More than 1 month since prior androgens for MDS

Radiotherapy

  • More than 12 months since prior radiotherapy for another disease* NOTE: *Not MDS or leukemia

Surgery

  • More than 1 month since prior surgery, including needle biopsy of visceral organs and recovered
  • Bone marrow biopsy allowed
  • More than 2 weeks since prior placement of a subcutaneous or tunneled venous access device (e.g., PortaCath or Hickman's catheter) and adequately healed

Other

  • No prior cytotoxic therapy for MDS
  • More than 1 month since prior administration of any of the following medications for MDS:
  • Danazol
  • Retinoids
  • Amifostine
  • Investigational agents
  • No concurrent administration of any of the following medications:
  • Warfarin
  • Heparin
  • Derivatives of heparin
  • Other anticoagulants
  • No concurrent grapefruit or grapefruit juice

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

United States68 sites

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Evanston Northwestern Healthcare - Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46815

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Mason District Hospital

    Havana, Illinois, 62644

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Maine Comprehensive Cancer Center at Central Maine Medical Center

    Lewiston, Maine, 04240

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11042

  • Mount Sinai Medical Center

    New York, New York, 10029

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Callahan Cancer Center at Great Plains Regional Medical Center

    North Platte, Nebraska, 69103

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Associates - Mercy Campus

    Oklahoma City, Oklahoma, 73120

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Center for Cancer Care at OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor (PTK787/ZK222584) (IND #66370, NSC #719335) in Myelodysplastic Syndrome (MDS)

RATIONALE: Vatalanib may be effective in preventing the development of leukemia in patients who have myelodysplastic syndromes.

PURPOSE: This phase II trial is studying vatalanib to see how well it works in treating patients with primary or secondary myelodysplastic syndromes.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the response rate, in terms of hematologic improvement and complete and partial remission, in patients with primary or secondary (therapy-related) myelodysplastic syndromes treated with vatalanib.
  • Determine the time to transformation to acute myeloid leukemia (at least 20% blasts) or death in patients treated with this drug.

Secondary

  • Determine the safety of this drug in these patients.
  • Determine the duration of response in patients treated with this drug.
  • Determine the cytogenetic response rate in patients treated with this drug.
  • Determine the overall and progression-free survival of patients treated with this drug.
  • Determine the incidence of infections requiring antibiotics or hospitalization or bleeding requiring red blood cell transfusions in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified* according to risk group (low grade [refractory anemia with or without ringed sideroblasts, refractory anemia with excess blasts-1, refractory cytopenia with multilineage dysplasia with or without ringed sideroblasts, myelodysplastic syndromes-unclassified, or chronic myelomonocytic leukemia-1] vs high grade [refractory anemia with excess blasts-2 or chronic myelomonocytic leukemia-2]).

NOTE: *Stratification according to risk (low vs high) does not occur after 11/30/06.

Patients receive oral vatalanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 6 additional courses after documentation of a CR.

Patients are followed periodically for up to 5 years from study entry.

PROJECTED ACCRUAL: Approximately 144 patients will be accrued for this study within 2.5 years.

Being tested
vatalanib
Keywords
refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, refractory anemia, previously treated myelodysplastic syndromes
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic, Myeloproliferative Disorders, Anemia, Refractory

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

    Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Study groups in NCT00072475
Study groupRoleWhat they receive
VatalanibExperimentalAdult patients with MDS receive treatment with vatalanib.
Receives: Drug: vatalanib

What is being measured

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

  1. Number of Participants With Response

    Response was measured by International Standardized Response Criteria for MDS

    • Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia
    • Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.

    Hematologic improvement:

    • Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements
    • Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L)
    • Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)

    Measured: Duration of study (up to 5 years)

  2. Time to Transformation to AML

    Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.

    Measured: Duration of study (up to 5 years)

Secondary outcomes (3)

  1. Duration of Response

    Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method.

    Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure).

    Measured: 5 yrs

  2. Overall Survival

    Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.

    Measured: Duration of study (up to 5 years)

  3. Progression-free Survival

    Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.

    Progression is defined as

    • For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts
    • For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts
    • For patients with 10-19% bone marrow blasts: increase to ≥20% blasts
    • One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent

    Progression after HI: Includes one or more of the following

    • Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L
    • Reduction in HGB concentration by at least 2 g/dL
    • Becoming transfusion dependent

    Measured: Duration of study (up to 5 years)

Timeline

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

  1. First posted6 Nov 2003 (estimated)
  2. Study startDec 2003
  3. Primary completionNov 2008
  4. Study completionJun 2014

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072475
Sponsor's protocol ID
CALGB-10105
Other IDs
U10CA031946, CALGB-10105, CDR0000339810
Status last verified
Jul 2016
First submitted
4 Nov 2003
Last updated
1 Aug 2016
Data monitoring committee
No

Publications

  • Gupta P, Miller AA, Owzar K, et al.: Pharmacokinetics of an oral VEGF receptor tyrosine kinase inhibitor (PTK787/ZK222584) in patients with myelodysplastic syndrome (MDS): Cancer and Leukemia Group B study 10105. [Abstract] J Clin Oncol 24 (Suppl 18): A-6573, 355s, 2006.

  • Gupta P, Mulkey F, Hasserjian RP, Sanford BL, Vij R, Hurd DD, Odenike OM, Bloomfield CD, Owzar K, Stone RM, Larson RA; Alliance for Clinical Trials in Oncology. A phase II study of the oral VEGF receptor tyrosine kinase inhibitor vatalanib (PTK787/ZK222584) in myelodysplastic syndrome: Cancer and Leukemia Group B study 10105 (Alliance). Invest New Drugs. 2013 Oct;31(5):1311-20. doi: 10.1007/s10637-013-9978-z. Epub 2013 May 23.

    PubMed 23700288

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vatalanib in people with Leukemia and Myelodysplastic Syndromes, run by Alliance for Clinical Trials in Oncology at 68 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: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 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?

Yes. Results are posted in the registry (first posted 24 Jun 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?

Number of Participants With Response (time frame: Duration of study (up to 5 years)). 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 NCT00072475, which also lists 2 linked publications.

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 1 Aug 2016.

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