Mesothelioma Clinical Trials
Combination
Chemotherapy and Tamoxifen in Treating Patients With Solid
Tumors
This study is currently
recruiting patients.
Ottawa Regional Cancer Centre
For more information:National
Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use 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 and chemotherapy may
kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of
combination chemotherapy consisting of cisplatin and
doxorubicin plus tamoxifen in treating patients who have solid
tumors.
| Condition
|
Treatment or
Intervention |
Cancer
|
Drug: cisplatin
Drug: doxorubicin
Drug: tamoxifen
Procedure: antiestrogen
therapy
Procedure: chemotherapy
Procedure: conventional
surgery
Procedure: drug
modulation
Procedure: endocrine
therapy
Procedure: hormone
therapy
Procedure: radiation
therapy
Procedure: surgery
|
This is a Phase II test
- In Phase II clinical trials, the study drug or treatment
is given to a larger group of people (100-300) to see if it
is effective and to further evaluate its safety.
Study Type: Interventional
Study
Design: Treatment
Official Title: Phase II Study of
Cisplatin, Doxorubicin, and Tamoxifen (CAT) in Patients With
Incurable Soft Tissue Sarcoma, Glioma, Mesothelioma, Hepatoma,
Thyroid Cancer, or Adrenal Cancer
Further Study Details:
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.
Ages Eligible for Study: up to 65 Years,
Genders Eligible for Study: Both
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
| 
