Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies


Phase 2
N/A
65 Years
Not Enrolling
Both
Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer, Liver Cancer, Malignant Mesothelioma, Pheochromocytoma, Sarcoma

Thank you

Trial Information

Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stan Z. Gertler, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Ottawa Regional Cancer Centre

Authority:

United States: Federal Government

Study ID:

CAN-OTT-9401

NCT ID:

NCT00002608

Start Date:

May 1994

Completion Date:

April 2005

Related Keywords:

  • Adrenocortical Carcinoma
  • Brain and Central Nervous System Tumors
  • Head and Neck Cancer
  • Liver Cancer
  • Malignant Mesothelioma
  • Pheochromocytoma
  • Sarcoma
  • 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
  • Carcinoma
  • Head and Neck Neoplasms
  • Liver Neoplasms
  • Mesothelioma
  • Nervous System Neoplasms
  • Pheochromocytoma
  • Central Nervous System Neoplasms
  • Adrenocortical Carcinoma
  • Sarcoma

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