NCT00003230

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with refractory or recurrent acute leukemia or chronic myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 leukemia

Timeline
Completed

Started Jan 1998

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2000

Completed
4 years until next milestone

First Posted

Study publicly available on registry

July 8, 2004

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2.5 years

First QC Date

November 1, 1999

Last Update Submit

May 14, 2012

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiablastic phase chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemia

Interventions

paclitaxelDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL) of B-cell or T-cell type, or blast crisis of chronic myelogenous leukemia (CML) Must fulfill one of the following criteria: - Newly diagnosed, previously untreated AML or ALL in elderly patients (65 75) - First or subsequent relapse of AML or ALL after standard chemotherapy, autologous or allogeneic bone marrow transplantation, or high-dose treatment with peripheral blood stem cell support - AML or ALL that is refractory to standard chemotherapy (no complete remission achieved after 2 courses of conventional induction chemotherapy) - CML in blast crisis of any subtype (i.e., myelogenous or lymphoblastic) with or without previously known chronic phase No leukemic involvement of the central nervous system PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: Creatinine less than 1.25 times ULN Cardiovascular: No history of atrial or ventricular arrhythmias No history of congestive heart failure, even if medically controlled No history of documented myocardial infarction Neurologic: No motor or sensory neuropathy grade 2 or more No dementia or significantly altered mental status Other: HIV negative No active infection or other serious underlying medical condition No prior allergic reaction to a drug containing Cremophor EL No complete bowel obstruction Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No required concurrent cytoreductive treatment in addition to paclitaxel No concurrent growth factors or cytokine No concurrent immunotherapeutic drugs Chemotherapy: No prior paclitaxel or related compounds for a malignancy other that leukemia No required concurrent cytoreductive treatment in addition to paclitaxel Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Office of Walter Weber-Stadelman

Basel, CH 4051, Switzerland

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Lugano, CH-6900, Switzerland

Location

Burgerspital, Solothurn

Solothurn, 4500, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaBlast Crisis

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Albert von Rohr, MD

    Klinik Hirslanden, Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 8, 2004

Study Start

January 1, 1998

Primary Completion

July 1, 2000

Study Completion

July 1, 2000

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CH(9)