NCT00002608

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Combining tamoxifen with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin and doxorubicin together with tamoxifen works in treating patients with solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 1994

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 1994

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

July 10, 2013

Status Verified

May 1, 2005

First QC Date

November 1, 1999

Last Update Submit

July 9, 2013

Conditions

Adrenocortical CarcinomaBrain and Central Nervous System TumorsHead and Neck CancerLiver CancerMalignant MesotheliomaPheochromocytomaSarcoma

Keywords

childhood brain tumorchildhood infratentorial ependymomachildhood supratentorial ependymomarecurrent adult soft tissue sarcomarecurrent childhood brain tumorchildhood liver cancerstage IV childhood liver cancerrecurrent childhood liver canceradvanced malignant mesotheliomarecurrent malignant mesotheliomalocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancerrecurrent adult brain tumorstage IV adrenocortical carcinomarecurrent adrenocortical carcinomastage IV papillary thyroid cancerstage IV follicular thyroid cancerthyroid gland medullary carcinomaanaplastic thyroid cancerrecurrent thyroid canceradult brain stem gliomaadult medulloblastomaadult glioblastomametastatic pheochromocytomarecurrent pheochromocytomachildhood soft tissue sarcomametastatic childhood soft tissue sarcomarecurrent childhood soft tissue sarcomachildhood high-grade cerebral astrocytomachildhood oligodendrogliomaadult anaplastic astrocytomaadult myxopapillary ependymomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult mixed gliomaadult pilocytic astrocytomaadult subependymomarecurrent childhood brain stem gliomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood medulloblastomarecurrent childhood visual pathway and hypothalamic gliomarecurrent childhood ependymomastage IV adult soft tissue sarcomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcomaadult diffuse astrocytoma

Interventions

cisplatinDRUG
doxorubicin hydrochlorideDRUG
tamoxifen citrateDRUG
conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer with clinical, radiological, or histologic evidence of incurability * Patients with thyroid cancer must have failed radioactive iodine * Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: * 65 and under Performance status: * ECOG 0-2 Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 140,000/mm3 Hepatic: * Bilirubin normal Renal: * Creatinine less than 1.47 mg/dL Cardiovascular: * Left ventricular ejection fraction at least 50% by MUGA scan * No congestive heart failure * No severe, uncontrolled hypertension * No ischemia, life-threatening arrhythmia, or conduction disturbance by ECG Other: * No allergy to study medications * No uncontrolled infection * No active abuse of ethanol that would preclude treatment * No other prior or concurrent malignancy * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 1 prior chemotherapy regimen * No prior anthracycline or cisplatin * At least 3 weeks since other prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy to more than 25% of bone marrow * At least 3 weeks since other prior radiotherapy and recovered 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 (1)

Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 1C4, Canada

Location

Related Publications (1)

  • Gertler SZ, Yau J, Stewart DJ, et al.: Cisplatin, doxorubicin and tamoxifen (CAT) in the treatment of incurable soft tissue and endocrine malignancies-preliminary results. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A1427, 1996.

    RESULT

MeSH Terms

Conditions

Adrenocortical CarcinomaCentral Nervous System NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsMesothelioma, MalignantPheochromocytomaSarcomaCarcinoma, HepatocellularBrain NeoplasmsThyroid Cancer, PapillaryAdenocarcinoma, FollicularCarcinoma, MedullaryThyroid Carcinoma, AnaplasticThyroid NeoplasmsMedulloblastomaGlioblastomaAstrocytomaOligodendrogliomaEpendymomaGliomaGlioma, SubependymalOptic Nerve GliomaFamilial ependymomaGliosarcoma

Interventions

CisplatinDoxorubicinTamoxifenRadiotherapy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System DiseasesNervous System NeoplasmsNervous System DiseasesDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesMesotheliomaAdenomaNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsPleural NeoplasmsLung DiseasesRespiratory Tract DiseasesParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplasms, Connective and Soft TissueBrain DiseasesCentral Nervous System DiseasesAdenocarcinoma, PapillaryThyroid DiseasesCarcinoma, NeuroendocrineNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, NeuroepithelialNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesStilbenesBenzylidene CompoundsBenzene DerivativesTherapeutics

Study Officials

  • Stan Z. Gertler, MD, FRCPC

    Ottawa Regional Cancer Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1994

Study Completion

April 1, 2005

Last Updated

July 10, 2013

Record last verified: 2005-05

Locations

CA(1)