Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar pregnancy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pemetrexed

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of low-risk post-molar gestational trophoblastic tumor, defined as 1 of the following:

• Increasing human chorionic gonadotropin (hCG) levels on ≥ 3 consecutive measurements taken over ≥ a 2-week period

• Less than 10% decrease of hCG levels on 4 measurements taken over ≥ a 3-week period

• Persistent or recurrent disease

• Histologically confirmed complete or partial mole on initial evacuation

• Prior pregnancy ≤ 12 months ago

• No histologically confirmed choriocarcinoma or placental site trophoblastic tumor on initial evacuation

• Failed only 1 prior dactinomycin or methotrexate therapy (with or without leucovorin calcium)

• WHO score 2-6

• No evidence of metastatic disease, except to the lung or vagina, on physical exam, chemistry, chest X-ray, and ultrasound

• No liver, spleen, brain, kidney, or gastrointestinal tract metastases

• No more than 8 metastatic lesions

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• GOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Granulocyte count ≥ 1,500/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• SGOT ≤ 3 times ULN

• Alkaline phosphatase ≤ 3 times ULN

Renal

• Creatinine ≤ 1.5 mg/dL

• Creatinine clearance ≥ 45 mL/min

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 3 months after study participation

• No significant infection

• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent prophylactic filgrastim (G-CSF) unless for recurrent neutropenic complications

• No concurrent prophylactic thrombopoietic agents unless for recurrent grade 4 thrombocytopenia

Chemotherapy

• See Disease Characteristics

• At least 7 days since prior dactinomycin or methotrexate (with or without leucovorin calcium) and recovered

• No prior pemetrexed disodium

• No other prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 14 days since prior radiotherapy and recovered

• No prior radiotherapy to ≥ 25% of the bone marrow

Surgery

• Recovered from prior surgery

Other

• No nonsteroidal anti-inflammatory drugs or salicylates for 2 days (or 5 days for drugs with a long half-life) before, during, and for 2 days after pemetrexed disodium administration

• Concurrent low-dose aspirin (≤ 325 mg/day) allowed