Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor - Full Text View

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00304070

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or surgery works in treating young patients with stage I, stage II, stage III or stage IV adrenocortical cancer.

Condition	Intervention	Phase
Adrenocortical Carcinoma	Drug: cisplatin Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: mitotane Drug: pegfilgrastim Procedure: conventional surgery	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Filgrastim Etoposide Cisplatin Etoposide phosphate Pegfilgrastim Mitotane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Primary tumor measurement [ Designated as safety issue: No ]
Measurable metastatic disease [ Designated as safety issue: No ]
Response of metastatic target lesions [ Designated as safety issue: No ]
Nonmeasurable metastatic disease [ Designated as safety issue: No ]
Overall response [ Designated as safety issue: No ]

Estimated Enrollment:	235
Study Start Date:	September 2006
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stratum I (stage I disease): Experimental Patients undergo primary tumor resection and retroperitoneal lymph node sampling followed by observation. Patients who have undergone prior surgery without nodal sampling undergo observation only.	Procedure: conventional surgery Patients undergo surgery
Stratum II (stage II disease): Experimental Patients undergo primary tumor resection and extended regional lymph node dissection followed by observation. Patients who have undergone prior surgery with simple resection of the primary tumor undergo exploratory surgery with extended regional lymph node dissection followed by observation.	Procedure: conventional surgery Patients undergo surgery
Stratum III (stage III or IV disease): Experimental Patients receive a combination chemotherapy with filgrastim (G-CSF) for up to 30 weeks (10 courses) followed by mitotane alone for an additional 2 months. Some patients undergo surgery after chemotherapy course 2 or 4. Some patients undergo additional surgery after finishing all chemotherapy.	Drug: cisplatin Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: filgrastim Given subcutaneously Drug: mitotane Given orally Drug: pegfilgrastim Given subcutaneously Procedure: conventional surgery Patients undergo surgery

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Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adrenocortical carcinoma
- Newly diagnosed disease within the past 3 weeks
- Any disease stage allowed

PATIENT CHARACTERISTICS:

Lansky performance status 60-100% (for patients ≤ 16 years old)
Karnofsky performance status 60-100% (for patients > 16 years old)
Absolute neutrophil count ≥ 750/mm^3
Platelet count ≥ 75,000/mm^3
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:
- ≤ 0.8 mg/dL (for patients ≤ 5 years old)
- ≤ 1.0 mg/dL (for patients 6 to 10 years old)
- ≤ 1.2 mg/dL (for patients 11 to 15 years old)
- ≤ 1.5 mg/dL (for patients > 15 years old)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST or ALT < 2.5 times ULN
Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

No previous chemotherapy for adrenocortical carcinoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304070

Show 60 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Carlos Rodriguez-Galindo, MD	St. Jude Children's Research Hospital
Investigator:	Raul C. Ribeiro, MD	St. Jude Children's Research Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000467191, COG-ARAR0332
Study First Received:	March 15, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00304070
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I adrenocortical carcinoma
stage II adrenocortical carcinoma
stage III adrenocortical carcinoma
stage IV adrenocortical carcinoma

Study placed in the following topic categories:

Adrenocortical Carcinoma
Adrenocortical carcinoma
Adrenal Gland Diseases
Endocrine System Diseases
Etoposide phosphate
Mitotane
Doxorubicin
Carcinoma
Adrenal Gland Neoplasms

Cisplatin
Adrenal Cortex Neoplasms
Endocrinopathy
Adrenal Cortex Diseases
Adenocarcinoma
Etoposide
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009