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Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00002608
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ottawa Regional Cancer Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Stan Z. Gertler, MD, FRCPC
Principal Investigator Affiliation Ottawa Regional Cancer Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer, Liver Cancer, Malignant Mesothelioma, Pheochromocytoma, Sarcoma
Additional 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ottawa, Ontario, Canada

Status

Address

Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 1C4

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