Adrenal Cortical CarcinomaPhase 2NCT00001339
A Study of Combination Chemotherapy and Surgical Resection in the Treatment of Adrenocortical Carcinoma: Continuous Infusion Doxorubicin, Vincristine and Etoposide With Daily Mitotane Before and After Surgical Resection
A Phase 2 study testing doxorubicin, vincristine, and etoposide with mitotane in people with Adrenal Cortical Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Patients who have no response to preoperative chemotherapy and no residual disease following surgery on Regimen A are treated on Regimen B postoperatively. The following acronyms are used: DDD Mitotane, NSC-38721 DOX Doxorubicin, NSC-123127 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Regimen A: 4-Drug… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adrenal Cortical Carcinoma
- What is being tested?
- doxorubicin, vincristine, and etoposide with mitotane
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1993to Aug 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Biopsy-proven primary or recurrent adrenocortical carcinoma considered surgically resectable at presentation or potentially resectable following an initial response to chemotherapy.
Potentially resectable disease includes primary lesion, nodal metastases, and liver and lung metastases if limited in size and number.
Patients for whom surgical resection is considered unlikely may be entered at the discretion of the investigator.
Measurable disease at presentation required.
A life expectancy of at least 3 months and a performance status (Karnofsky scale) of 70 percent or greater.
Prior chemotherapy is allowed, however, the patient should not have received chemotherapy four weeks before presentation.
Patients who have received prior doxorubicin may be enrolled provided they meet all other entry criteria and have an ejection fraction greater than 40 percent determined by MUGA scan.
Prior mitotane therapy is allowed. A dose of 3 gm/day should have been tolerated for at least one week. Patients do not need to be off mitotane therapy prior to starting this protocol.
WBC greater 3,000/mm(3); Platelet count greater than 100,000/mm(3); Creatinine clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; serum transaminase less than 2 times normal.
Patient should be a good surgical candidate.
Must sign an informed consent and be geographically accessible to return for follow up treatment.
No presence of a second malignancy, other than squamous cell carcinoma of the skin.
No active systemic infection.
Must not be currently receiving treatment which cannot be discontinued with the following agents: diltiazem, nicardipine, phenothiazines, phenytoin, terfenadine or verapamil.
No positive serology for HIV.
No positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Patients who have no response to preoperative chemotherapy and no residual disease following surgery on Regimen A are treated on Regimen B postoperatively.
The following acronyms are used:
DDD Mitotane, NSC-38721
DOX Doxorubicin, NSC-123127
VCR Vincristine, NSC-67574
VP-16 Etoposide, NSC-141540
Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by DDD/DOX/VCR/VP-16.
Regimen B: Single-Agent Chemotherapy. DDD.
Read the detailed description
This is a study of infusional doxorubicin, vincristine, and etoposide in combination with daily oral mitotane in patients with adrenocortical cancer. Although mitotane has been used extensively in adrenocortical cancer and has documented single agent activity, only limited experience is available in the use of mitotane in combination with chemotherapy. In this trial the primary reason for using mitotane is an attempt to enhance therapeutic efficacy, based on its documented in-vitro activity as an antagonist of P-glycoprotein. The goal of this study is to determine the efficacy of this therapy by treating patients who are considered candidates for surgical resection at presentation or following a response to therapy. Following chemotherapy, patients deemed surgical candidates can undergo surgical resection with evaluation of response. Patients responding to chemotherapy will resume the combination treatment after surgery. Patients who do not respond will be maintained on single agent mitotane until it is deemed ineffective.
- Conditions
- Adrenal Cortical Carcinoma
- Being tested
- doxorubicin, vincristine, and etoposide with mitotane
- Keywords
- Multidrug Resistance, Reversal of Drug Resistance, P-Glycoprotein, MDR-1
- Medical subject headings
- Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin, vincristine, and etoposide with mitotaneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1993
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adrenal Cortical CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001339
- Sponsor's protocol ID
- 930200
- Other IDs
- 93-C-0200
- Status last verified
- Aug 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Luton JP, Cerdas S, Billaud L, Thomas G, Guilhaume B, Bertagna X, Laudat MH, Louvel A, Chapuis Y, Blondeau P, et al. Clinical features of adrenocortical carcinoma, prognostic factors, and the effect of mitotane therapy. N Engl J Med. 1990 Apr 26;322(17):1195-201. doi: 10.1056/NEJM199004263221705.
PubMed 2325710Bates SE, Shieh CY, Mickley LA, Dichek HL, Gazdar A, Loriaux DL, Fojo AT. Mitotane enhances cytotoxicity of chemotherapy in cell lines expressing a multidrug resistance gene (mdr-1/P-glycoprotein) which is also expressed by adrenocortical carcinomas. J Clin Endocrinol Metab. 1991 Jul;73(1):18-29. doi: 10.1210/jcem-73-1-18.
PubMed 1675220Cohn K, Gottesman L, Brennan M. Adrenocortical carcinoma. Surgery. 1986 Dec;100(6):1170-7.
PubMed 3787475
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Combination Chemotherapy and Surgical Resection in the Treatment of Adrenocortical Carcinoma: Continuous Infusion Doxorubicin, Vincristine and Etoposide With Daily Mitotane Before and After Surgical Resection
- ClinicalTrials.gov ID
- NCT00001339
- Acronym / sponsor ID
- 930200
- Conditions
- Adrenal Cortical Carcinoma
- Keywords
- Multidrug Resistance, Reversal of Drug Resistance, P-Glycoprotein, MDR-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 1993
- Study completion
- Aug 2002
- First posted
- 4 Nov 1999 (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.
Patients who have no response to preoperative chemotherapy and no residual disease following surgery on Regimen A are treated on Regimen B postoperatively.
The following acronyms are used:
DDD Mitotane, NSC-38721
DOX Doxorubicin, NSC-123127
VCR Vincristine, NSC-67574
VP-16 Etoposide, NSC-141540
Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by DDD/DOX/VCR/VP-16.
Regimen B: Single-Agent Chemotherapy. DDD.
Detailed description
This is a study of infusional doxorubicin, vincristine, and etoposide in combination with daily oral mitotane in patients with adrenocortical cancer. Although mitotane has been used extensively in adrenocortical cancer and has documented single agent activity, only limited experience is available in the use of mitotane in combination with chemotherapy. In this trial the primary reason for using mitotane is an attempt to enhance therapeutic efficacy, based on its documented in-vitro activity as an antagonist of P-glycoprotein. The goal of this study is to determine the efficacy of this therapy by treating patients who are considered candidates for surgical resection at presentation or following a response to therapy. Following chemotherapy, patients deemed surgical candidates can undergo surgical resection with evaluation of response. Patients responding to chemotherapy will resume the combination treatment after surgery. Patients who do not respond will be maintained on single agent mitotane until it is deemed ineffective.
Study design
- Primary purpose
- Treatment
Who may qualify
- 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 |
|---|---|---|
| doxorubicin, vincristine, and etoposide with mitotane | Drug | – |
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 4 Mar 2008.
- Background: PubMed 2325710Luton JP, Cerdas S, Billaud L, Thomas G, Guilhaume B, Bertagna X, Laudat MH, Louvel A, Chapuis Y, Blondeau P, et al. Clinical features of adrenocortical carcinoma, prognostic factors, and the effect of mitotane therapy. N Engl J Med. 1990 Apr 26;322(17):1195-201. doi: 10.1056/NEJM199004263221705.
- Background: PubMed 1675220Bates SE, Shieh CY, Mickley LA, Dichek HL, Gazdar A, Loriaux DL, Fojo AT. Mitotane enhances cytotoxicity of chemotherapy in cell lines expressing a multidrug resistance gene (mdr-1/P-glycoprotein) which is also expressed by adrenocortical carcinomas. J Clin Endocrinol Metab. 1991 Jul;73(1):18-29. doi: 10.1210/jcem-73-1-18.
- Background: PubMed 3787475Cohn K, Gottesman L, Brennan M. Adrenocortical carcinoma. Surgery. 1986 Dec;100(6):1170-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 doxorubicin, vincristine, and etoposide with mitotane in people with Adrenal Cortical Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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 NCT00001339, which also lists 3 linked publications.
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 4 Mar 2008.