Phase 3
Completed N=240
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Good Prognosis Metastatic Gestational Trophoblastic Tumor · Hydatidiform Mole · Non-Metastatic Gestational Trophoblastic Tumor · Uterine Corpus Choriocarcinoma
Source: ClinicalTrials.gov NCT00003702 ↗
Enrolled (actual)
240
Serious AEs
0.5%
Results posted
May 2018
Primary outcomePrimary: Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay — 57; 76; 48; 29 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay |
57; 76; 48; 29; 2; 4 | — |
| PRIMARY Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 |
14; 20 | — |
| SECONDARY Number of Patients With a Decline of hCG on Day 1 of Treatment |
72 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
- Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
- Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
- Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)
- Histologically proven nonmetastatic choriocarcinoma
- Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)
- 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
Data sourced from ClinicalTrials.gov (NCT00003702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.