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Status:

COMPLETED

Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer

Lead Sponsor:

University of Arizona

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Fallopian Tube Cancer

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to...

Detailed Description

OBJECTIVES: Primary * To determine the maximum-tolerated dose (MTD) of combination therapy comprising intraperitoneal (IP) pemetrexed disodium in combination with IP cisplatin and paclitaxel in pati...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or pathologically confirmed ovarian epithelial carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma
  • Stage III disease
  • Meets 1 of the following criteria:
  • No prior treatment and no more than 6 months since primary surgery
  • Platinum-sensitive at second-look surgery with no prior cisplatin therapy
  • Must have been optimally debulked to less than 2-cm residual individual tumor plaques or, if suboptimally debulked at first surgery, had chemical debulking
  • No mixed Müllerian tumor or borderline ovarian tumor
  • No Central nervous system (CNS) or brain metastases
  • PATIENT CHARACTERISTICS:
  • Gynecologic Oncology Group performance status 0-2
  • White blood cell count(WBC) ≥ 3,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Serum bilirubin ≤ 2 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after discontinuation of study drug
  • No psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol
  • No unstable or preexisting major medical conditions, except cancer-related abnormalities
  • No medical life-threatening complications of their malignancies
  • No known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV)
  • No serious active uncontrolled infections
  • No inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg on antihypertensive medications)
  • No New York Heart Association grade II-IV congestive heart failure
  • No weight loss between 5 to ≤ 10% within the past 14 days that is not related to ascites or paracentesis
  • No prior hypertensive crisis or hypertensive encephalopathy
  • No myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within the past 6 months
  • No evidence of uncontrollable nausea
  • No clinically significant or symptomatic peripheral vascular disease (e.g., aortic aneurysm or aortic dissection)
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  • No pre-existing clinically significant hearing loss
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or adequately treated stage I or II cancer from which the patient is in complete remission
  • No known hypersensitivity to any component of pemetrexed disodium
  • Able to take folic acid, vitamin B\_12, and dexamethasone according to protocol
  • No presence of third-space fluid that cannot be controlled by drainage
  • No inability to comply with study and/or follow-up procedures
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • May have received up to 4 courses of carboplatin and paclitaxel IV as neoadjuvant chemotherapy for advanced, unresectable disease
  • Concurrent low-dose aspirin therapy (i.e., 325 mg/day) allowed
  • Concurrent ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) with short elimination half-lives allowed provided ≥ 1 of the following criteria is met:
  • Creatinine clearance (CrCl) \> 80 mL/min (i.e., normal renal function)
  • CrCl 45-79 mL/min (i.e., mild to moderate renal insufficiency) AND NSAID dosing interrupted for a period of 2 days before, during, and 2 days after administration of pemetrexed disodium
  • Concurrent NSAIDs or salicylates with long half-lives (e.g., naproxen, piroxicam, diflunisal, or nabumetone) allowed provided NSAID dosing is interrupted for at least 5 days before, during, and 2 days after administration of pemetrexed disodium
  • No concurrent antineoplastic or antitumor agents not part of the study therapy (i.e., chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy)
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    September 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2012

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT00702299

    Start Date

    September 1 2007

    End Date

    October 1 2012

    Last Update

    January 1 2016

    Active Locations (2)

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

    Page 1 of 1 (2 locations)

    1

    Arizona Oncology - Scottsdale

    Scottsdale, Arizona, United States, 85258

    2

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724-5024