Brief Title
Pemetrexed Disodium and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma
Brief Summary
This phase II trial studies how well pemetrexed disodium and carboplatin work in treating
patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in
chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the response rate of combination pemetrexed (pemetrexed disodium) (Alimta) and
carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube
carcinoma.
SECONDARY OBJECTIVES:
I. To evaluate the progression free interval, overall survival, and adverse effects among
patients receiving this drug combination.
OUTLINE:
Patients receive pemetrexed disodium intravenously (IV) over 8-15 minutes and carboplatin IV
over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the
absence of disease progression or unacceptable toxicity.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall objective response rate (RR) based on Response Evaluation Criteria in Solid Tumors and by Rustin Criteria (RECIST)
Secondary Outcome
Incidence of toxicities assessed according to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0.
Condition
Recurrent Fallopian Tube Carcinoma
Intervention
Carboplatin
Study Arms / Comparison Groups
Treatment (pemetrexed disodium, carboplatin)
Description: Patients receive pemetrexed disodium IV over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
July 2008
Completion Date
February 2015
Primary Completion Date
January 2015
Eligibility Criteria
Inclusion Criteria:
- Patients must have a histopathologically confirmed diagnosis of epithelial ovarian,
primary peritoneal, or fallopian tube carcinoma
- Patients must have received at least 1 prior platinum and taxane based chemotherapy
regimen; patients may have failed no more than 2 prior chemotherapy regimens
- Patients must have "platinum sensitive" disease, which will be defined as those
patients with relapsed disease who had an initial complete remission, and relapsed
more than 6 months after completion of initial platinum based chemotherapy
- Recurrent disease must be confirmed by:
- Bidimensionally measurable disease which can be measured by physical examination
or by means of medical imaging techniques (measurable disease)
- Measurable disease is defined as at least one lesion that can be accurately
measured in at least one dimension (longest dimension to be recorded); each
lesion must be >= 2.0 cm when measured by conventional techniques, including
palpation, x-ray, computed tomography (CT), and magnetic resonance imaging
(MRI), or >= 1.0 cm when measured by spiral CT; all measurable lesions up to
a maximum of 5 lesions per organ and 10 lesions in total representative of
all involved organs should be identified as target lesions and will be
recorded and measured at baseline; all baseline evaluations of disease
status should be performed as close as possible to the start of treatment
and never more than 4 weeks before the beginning of treatment
- Target lesions should be selected on the basis of their size (lesions with
the longest dimension, LD) and their suitability for accurate repetitive
measurements by one consistent method of assessment (either clinically or by
imaging techniques); a sum of LD for all target lesions will be calculated
and reported as the baseline sum LD; the baseline sum LD will be used as
reference to further characterize the objective tumor response of the
measurable dimension of the disease; all other lesions (or sites of disease)
should be identified as non-target lesions and should also be recorded at
baseline OR
- Two confirmed serum cancer antigen-125 (CA-125) levels greater than or equal to
70 u/ml (or 2 x upper limit of normal) separated by 1 week and obtained within 4
weeks prior to entry to the study (evaluable disease)
- Patients must not have had other myelosuppressive therapy within four weeks of
initiating pemetrexed/ carboplatin therapy
- Patients must have recovered from effects of recent surgery
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
- White blood cell (WBC) greater than or equal to 3,000/ul
- Platelet count greater or equal to 100,000/ul
- Neutrophil count greater or equal to 1,500/ul
- Creatinine clearance >= 45 ml/min (estimated creatinine clearance by Cockcroft-Gault
equation acceptable)
- Total bilirubin =< to 1.5 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
transaminase (SGPT) =< three times the upper normal institutional limits; if patient
has known hepatic metastases, patients may be enrolled if liver function test is =<
five times the upper normal institutional limits
- Alkaline phosphatase =< three times the upper normal institutional limits; if patient
has known hepatic metastases, patients may be enrolled if liver function test is =<
five times the upper normal institutional limits
- Patient must have signed informed consent
- Patients must be willing to take the dexamethasone, folic acid and vitamin B12
supplementation as indicated in the protocol to reduce adverse drug toxicity
- Patients must be willing to interrupt aspirin and other nonsteroidal anti-inflammatory
drugs (NSAID) intake for 2 days before, day of, and 2 days after each chemotherapy
treatment; low dose 80 mg aspirin and cyclooxygenase-2 (Cox-2) inhibitors are excluded
from this restriction; if concomitant administration of an NSAID is necessary,
patients should be monitored closely
- Patients must have a life expectancy of greater than 12 weeks
- Patients may not have concurrent or previous invasive malignancies, with the exception
of non-melanoma skin cancer or no evidence of recurrence of previous malignancy within
the last 5 years
- Patients must have a current exam, blood work and any clinically indicated imaging
studies within 4 weeks prior to study enrollment
- Baseline folate and homocysteine blood levels
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day
of, and 2 days following administration of Alimta
- The ability to take folic acid, vitamin B12, and dexamethasone according to protocol
Exclusion Criteria:
- Patients who have had more than two prior chemotherapeutic regimens
- Patients who have had prior treatment with pemetrexed
- Patients with a GOG performance status of 3 or 4
- Patients with >= grade 2 neuropathy
- Patients who have received external beam whole pelvic or whole abdominal radiation
treatment (>= 4500 centigray [cGy]) which would limit vascular capacity and reduce
adequate drug delivery
- Patients with evidence of recurrence from another malignancy within the previous five
years
- Patients with a concomitant malignancy other than squamous cell skin cancer
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection, unstable angina pectoris, or psychiatric illness/social
situations that would limit compliance with study requirements
- Patients who have received an investigational drug within the last 30 days that has
not received regulatory approval
- Presence of third space fluid which cannot be controlled by drainage; for patients who
develop or have baseline clinically significant pleural or peritoneal effusions (on
the basis of symptoms or clinical examination) before or during initiation of Alimta
therapy, consideration should be given to draining the effusion prior to dosing;
however, if, in the investigator's opinion, the effusion represents progression of
disease, the patient should be discontinued from study therapy
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Dennis Kuo, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01001910
Organization ID
08-04-097
Secondary IDs
NCI-2013-01208
Responsible Party
Principal Investigator
Study Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Dennis Kuo, Principal Investigator, Albert Einstein College of Medicine
Verification Date
March 2015