Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor
This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00304070
First received: March 15, 2006
Last updated: November 3, 2012
Last verified: November 2012
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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 |
Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: etoposide Drug: mitotane Procedure: conventional surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Mitotane
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Pegfilgrastim
U.S. FDA Resources
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: | 79 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stratum I (stage I disease)
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
|
|
Experimental: Stratum II (stage II disease)
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
|
|
Experimental: Stratum III (stage III or IV disease)
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.
|
Biological: filgrastim
Given subcutaneously
Biological: pegfilgrastim
Given subcutaneously
Drug: cisplatin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: mitotane
Given orally
Procedure: conventional surgery
Patients undergo surgery
|
Show Detailed Description 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:
- 0.4 mg/dL (1 month to < 6 months)
- 0.5 mg/dL (6 months to < 1 year of age)
- 0.6 mg/dL (1 to < 2 years of age
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
- 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 83 Study Locations
Show 83 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Carlos Rodriguez-Galindo, MD | Dana-Farber Cancer Institute |
| Investigator: | Raul C. Ribeiro, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00304070 History of Changes |
| Other Study ID Numbers: | CDR0000467191, COG-ARAR0332 |
| Study First Received: | March 15, 2006 |
| Last Updated: | November 3, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Adrenocortical Carcinoma Adrenal Cortex Neoplasms Carcinoma Adrenal Gland Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Cisplatin |
Doxorubicin Etoposide Mitotane Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic Antineoplastic Agents, Hormonal Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013