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A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor


Phase 2
N/A
N/A
Not Enrolling
Female
Gestational Trophoblastic Tumor

Thank you

Trial Information

A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor


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 dactinomycin or methotrexate.

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21
days in the absence of unacceptable toxicity or disease progression or until tumor marker
levels (human chorionic gonadotropin [hCG]) become normal. Patients receive 2 additional
courses beyond the attainment of a normal hCG.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed
disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12)
intramuscularly every 9 weeks.

Patients are followed every 2 weeks for 2 months and then monthly for 10 months.

PROJECTED ACCRUAL: Approximately 17-55 patients will be accrued for this study within 20-50
months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Activity

Safety Issue:

No

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000390347

NCT ID:

NCT00096187

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Gestational Trophoblastic Tumor
  • low risk metastatic gestational trophoblastic tumor
  • recurrent gestational trophoblastic tumor
  • nonmetastatic gestational trophoblastic tumor
  • Hydatidiform Mole
  • Trophoblastic Neoplasms
  • Gestational Trophoblastic Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Wilson Medical CenterWilson, North Carolina  27893-3428
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirmingham, Alabama  35294