Adrenocortical CarcinomaPhase 2NCT00002608
Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors
A Phase 2 study testing cisplatin, doxorubicin hydrochloride and tamoxifen citrate in people with Adrenocortical Carcinoma and Brain and Central Nervous System Tumors, run by Ottawa Regional Cancer Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer
- What is being tested?
- cisplatin, doxorubicin hydrochloride and tamoxifen citrate
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 1994to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 locations and contacts
1 site in 1 country.
Canada1 site
Ottawa Regional Cancer Centre at Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 1C4
About this study
Official title: Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
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.
Read the 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.
- Conditions
- Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer, Liver Cancer, Malignant Mesothelioma, Pheochromocytoma
- Being tested
- cisplatin, doxorubicin hydrochloride, tamoxifen citrate, conventional surgery, radiation therapy
- 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
- Medical subject headings
- Adrenocortical Carcinoma, Central Nervous System Neoplasms, Head and Neck Neoplasms, Liver Neoplasms, Mesothelioma, Malignant, Pheochromocytoma, Sarcoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
tamoxifen citrateDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 1994
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Regional Cancer Centre
- Sponsor type
- University, hospital or other
- Investigators
- Stan Z. Gertler, MD, FRCPC, Study chair, Ottawa Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002608
- Sponsor's protocol ID
- CAN-OTT-9401
- Other IDs
- CDR0000063892, NCI-V94-0566
- Status last verified
- May 2005
- First submitted
- 1 Nov 1999
- Last updated
- 10 Jul 2013
- Results posted
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies
- ClinicalTrials.gov ID
- NCT00002608
- Acronym / sponsor ID
- CAN-OTT-9401
- Conditions
- Adrenocortical Carcinoma, Brain and Central Nervous System Tumors, Head and Neck Cancer, Liver Cancer, Malignant Mesothelioma, Pheochromocytoma
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Regional Cancer CentreUniversity, hospital or other
- Study start
- May 1994
- Study completion
- Apr 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| tamoxifen citrate | Drug | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
- Results publicationGertler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stan Z. Gertler, MD, FRCPC study chair
Ottawa Regional Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, doxorubicin hydrochloride and tamoxifen citrate in people with Adrenocortical Carcinoma and Brain and Central Nervous System Tumors, run by Ottawa Regional Cancer Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.