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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Primary Purpose

Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
cisplatin
doxorubicin hydrochloride
tamoxifen citrate
conventional surgery
radiation therapy
Sponsored by
Ottawa Regional Cancer Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenocortical Carcinoma focused on measuring childhood brain tumor, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent adult soft tissue sarcoma, recurrent childhood brain tumor, childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, advanced malignant mesothelioma, recurrent malignant mesothelioma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent adult brain tumor, stage IV adrenocortical carcinoma, recurrent adrenocortical carcinoma, stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, anaplastic thyroid cancer, recurrent thyroid cancer, adult brain stem glioma, adult medulloblastoma, adult glioblastoma, metastatic pheochromocytoma, recurrent pheochromocytoma, childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, recurrent childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood ependymoma, stage IV adult soft tissue sarcoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 9, 2013
Sponsor
Ottawa Regional Cancer Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00002608
Brief Title
Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
Official Title
Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
May 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ottawa Regional Cancer Centre

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the feasibility and efficacy of cisplatin, doxorubicin, and tamoxifen (CAT) in patients with soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer. Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive cisplatin IV over 1-2 hours followed immediately by doxorubicin IV over 15-30 minutes on days 1-3 and oral tamoxifen twice daily on days 4-17. Treatment continues every 3 weeks in the absence of the total cumulative doxorubicin dose reaching at least 500 mg/m2, disease progression, or unacceptable toxicity. Patients who achieve partial remission (PR) undergo local surgery or radiotherapy, if feasible, to convert PR to complete remission. Patients are followed every 2 months for 1 year and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer, Liver Cancer, Malignant Mesothelioma, Pheochromocytoma, Sarcoma
Keywords
childhood brain tumor, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent adult soft tissue sarcoma, recurrent childhood brain tumor, childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, advanced malignant mesothelioma, recurrent malignant mesothelioma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent adult brain tumor, stage IV adrenocortical carcinoma, recurrent adrenocortical carcinoma, stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, anaplastic thyroid cancer, recurrent thyroid cancer, adult brain stem glioma, adult medulloblastoma, adult glioblastoma, metastatic pheochromocytoma, recurrent pheochromocytoma, childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, recurrent childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood ependymoma, stage IV adult soft tissue sarcoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Z. Gertler, MD, FRCPC
Organizational Affiliation
Ottawa Regional Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

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