Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Liver Cancer
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:
NCT00980460
First received: September 18, 2009
Last updated: November 22, 2012
Last verified: November 2012
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Purpose
RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether surgery is more effective with or without chemotherapy or which chemotherapy regimen may be more effective in treating young patients with liver cancer.
PURPOSE: This phase III trial is studying the side effects of giving doxorubicin hydrochloride together with combination chemotherapy and to compare different chemotherapy regimens to see how well they work in treating young patients with newly diagnosed liver cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: irinotecan hydrochloride Drug: vincristine sulfate Procedure: liver transplantation Procedure: therapeutic conventional surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Children With All Stages of Hepatoblastoma |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Vincristine sulfate
Sulfate ion
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
Irinotecan
Irinotecan hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Survival rate [ Designated as safety issue: No ]
- Disease status at the end of 2 courses of therapy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Feasibility of referral for liver transplantation [ Designated as safety issue: No ]
| Estimated Enrollment: | 216 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Very low-risk group
Patients undergo surgery and then receive no further treatment.
|
Procedure: therapeutic conventional surgery
Patients undergo surgery
|
|
Experimental: Low-risk group (regimen T)
Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV on day 2, and vincristine sulfate IV on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: cisplatin
given IV
Drug: fluorouracil
given IV
Drug: vincristine sulfate
given IV
Procedure: therapeutic conventional surgery
Patients undergo surgery
|
|
Experimental: Intermediate-risk group (regimen F)
Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV on day 2, vincristine sulfate IV on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD.
|
Drug: cisplatin
given IV
Drug: doxorubicin hydrochloride
given IV
Drug: fluorouracil
given IV
Drug: vincristine sulfate
given IV
Procedure: liver transplantation
May undergo transplant after 4 courses of chemotherapy
Procedure: therapeutic conventional surgery
Patients undergo surgery
|
|
Experimental: High-risk group (regimen W)
Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Responding patients then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block and non-responding patients receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplantation after course 4 of C5VD followed by 2 courses of adjuvant C5VD.
|
Drug: cisplatin
given IV
Drug: doxorubicin hydrochloride
given IV
Drug: fluorouracil
given IV
Drug: irinotecan hydrochloride
given IV
Drug: vincristine sulfate
given IV
Procedure: liver transplantation
May undergo transplant after 4 courses of chemotherapy
Procedure: therapeutic 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 newly diagnosed hepatoblastoma
- All stages* and all histologic variants allowed NOTE: *Patients with Stage I or II disease must have specimens submitted for rapid central pathology review by Day 14 after initial surgical resection
Patients are assigned to the following risk groups:
- Very low-risk: grossly resected tumors (stage I) with PFH AND an elevated AFP level > 100 ng/mL
- Low-risk: grossly resected tumors (stage I-II) AND lacking any unfavorable biologic feature (i.e., any SCU elements or a low diagnostic AFP level < 100 ng/mL)
- Intermediate-risk: gross residual disease/unresectable disease OR grossly resected disease with any SCU elements but no metastatic disease and no low diagnostic AFP level < 100 ng/mL
- High-risk: metastatic disease OR low diagnostic AFP level < 100 ng/mL regardless of stage
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC* > 750/μL
- Platelet count* > 75,000/μL
Creatinine clearance* or radioisotope glomerular filtration rate* ≥ 70 mL/min OR serum creatinine* based on age/gender as follows:
- 1 month to < 6 months: 0.4 mg/dL
- 6 months to < 1 year: 0.5 mg/dL
- 1 to < 2 years: 0.6 mg/dL
- 2 to < 6 years: 0.8 mg/dL
- 6 to < 10 years: 1 mg/dL
- 10 to < 13 years: 1.2 mg/dL
- 13 to < 16 years: 1.5 mg/dL (male) or 1.4 mg/dL (female)
- ≥ 16 years: 1.7 mg/dL (male) 1.4 mg/dL (female)
- Total bilirubin* < 1.5 times upper limit of normal (ULN) for age
- SGOT (AST)* or SGPT (ALT)* < 10 times ULN for age
- Shortening fraction** ≥ 27% by echocardiogram
- Ejection fraction** ≥ 47% by radionuclide angiogram (MUGA)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception NOTE: *Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy.
NOTE: **For intermediate- and high-risk patients who will be assigned to protocol chemotherapy.
PRIOR CONCURRENT THERAPY:
- Prior surgical resection of some or all sites of hepatoblastoma allowed
- No prior chemotherapy for hepatoblastoma or other hepatoblastoma-directed therapy (e.g., radiation therapy, biologic agents, local therapy [embolization, radiofrequency ablation, laser])
- No other prior chemotherapy
- No concurrent radiotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980460
Show 161 Study Locations
Show 161 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Howard M. Katzenstein, MD | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00980460 History of Changes |
| Other Study ID Numbers: | CDR0000654889, COG-AHEP0731 |
| Study First Received: | September 18, 2009 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
childhood hepatoblastoma stage I childhood liver cancer stage II childhood liver cancer stage III childhood liver cancer stage IV childhood liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Hepatoblastoma Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type Irinotecan Cisplatin Doxorubicin Fluorouracil Vincristine Camptothecin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013