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Status:

TERMINATED

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

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Gestational Trophoblastic Tumor

Eligibility:

FEMALE

Up to 120 years

Phase:

PHASE2

Brief 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 ...

Detailed Description

OBJECTIVES: * Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomy...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    55 Patients enrolled

    Trial Details

    Trial ID

    NCT00096187

    Start Date

    July 1 2005

    Last Update

    April 12 2018

    Active Locations (25)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (25 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Providence Saint Joseph Medical Center - Burbank

    Burbank, California, United States, 91505

    3

    Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, United States, 92868

    4

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013