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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02026 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ECOG-G174 | |||
| CDR0000066809 | |||
| GOG-0174 | Other Identifier | Gynecologic Oncology Group | |
| GOG-0174 | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eastern Cooperative Oncology Group | NETWORK |
| National Cancer Institute (NCI) | NIH |
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
OBJECTIVES:
I. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.
II. Compare the toxicity of these regimens in these patients. III. Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate (as determined by the likelihood that the beta human chorionic gonadotropin [HCG] titer would decline on the day treatment is initiated).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. All patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
Patients are followed every 4 weeks for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (methotrexate) | Experimental | Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment. |
|
| Arm II (dactinomycin) | Experimental | Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dactinomycin | Biological | Given IV |
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|
| Measure | Description | Time Frame |
|---|---|---|
| Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay | Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements. | Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months. |
| Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 | Number of participants with a maximum grade of 3 or higher during the treatment period. | Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Decline of hCG on Day 1 of Treatment | Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start. | Prior to study entry and on Day 1 of treatment |
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Inclusion Criteria:
Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
WHO score 0-6 (not including blood group or CT lung)
No histologically confirmed placental site pseudotumor
Must have undergone at least 1 uterine curettage
Previously untreated disease
Performance status - GOG 0-2
WBC at least 3,000/mm^3
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGPT and SGOT no greater than 3 times ULN
Alkaline phosphatase no greater than 3 times ULN
No significant prior abnormal hepatic function
Creatinine no greater than 2.0 mg/dL
No significant prior abnormal renal function
Not pregnant or nursing
Fertile patients must use effective contraception during and for one year after study entry
No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer
No prior chemotherapy for gestational trophoblastic neoplasia
No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Osborne | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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This trial opened to patient accrual on 6/14/1999 and closed to accrual on 2/26/2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Methotrexate 30 mg/m2 IM Weekly | Arm 1: Methotrexate 30 mg/m2 IM weekly |
| FG001 | Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks | Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Methotrexate | Drug | Given intramuscularly |
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| COMPLETED |
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| NOT COMPLETED |
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Eligible participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Methotrexate 30 mg/m2 IM Weekly | Arm 1: Methotrexate 30 mg/m2 IM weekly |
| BG001 | Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks | Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay | Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements. | Eligible patients who received a random treatment allocation | Posted | Count of Participants | Participants | No | Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months. |
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| Primary | Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 | Number of participants with a maximum grade of 3 or higher during the treatment period. | Eligible and treated patients | Posted | Count of Participants | Participants | Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months. |
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| Secondary | Number of Patients With a Decline of hCG on Day 1 of Treatment | Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start. | Eligible and evaluated patients | Posted | Count of Participants | Participants | No | Prior to study entry and on Day 1 of treatment |
|
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Through Study completion, an average of 7 months.
The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Methotrexate 30 mg/m2 IM Weekly | Arm 1: Methotrexate 30 mg/m2 IM weekly | 0 | 107 | 50 | 107 | ||
| EG001 | Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks | Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks | 1 | 107 | 68 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Other Hemotologic | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Allergy | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Auditory | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Cardiovascular | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Coagulation | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Constitutional | General disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Dermatologic | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Endocrine | Endocrine disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Genitourinary/Renal | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Hemorrhage | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Hepatic | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Infection/Fever | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
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| Metabolic | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Neurologic | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Ocular/Visual | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Sexual | Reproductive system and breast disorders | CTCAE (2.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela M. Kuras on behalf of Virginia Filiaci | NRG Oncology | 7168455702 | kurasa@nrgoncology.org |
| ID | Term |
|---|---|
| D006828 | Hydatidiform Mole |
| ID | Term |
|---|---|
| D031901 | Gestational Trophoblastic Disease |
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003609 | Dactinomycin |
| D008727 | Methotrexate |
| C015342 | merphos |
| ID | Term |
|---|---|
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Male |
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| Inevaluable |
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