Pemetrexed and Carboplatin in Recurrent Platinum Sensitive Ovarian Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01001910
First received: October 26, 2009
Last updated: July 7, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Drug: Carboplatin
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • To evaluate the response rate of combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube carcinoma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the progression free interval, overall survival, and adverse effects among patients receiving this drug combination. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: April 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Carboplatin
    The diluted solution of Carboplatin will be infused via a peripheral or central vein over 30-60 minutes, immediately following the Pemetrexed infusion, every 21 days.
    Other Name: Paraplatin
    Drug: Pemetrexed
    The diluted solution will be infused via a peripheral or central vein over 10 minutes, every 21 days.
    Other Name: Alimta
Detailed Description:
  • Before patients receive any chemotherapy treatments they will be given three medications to prevent side effects from the chemotherapy drugs. These medications are vitamin B12, folic acid and dexamethasone.
  • Chemotherapy treatments will be given intravenously in the outpatient clinic. Pemetrexed will be given first and will take 10 minutes to infuse followed by carboplatin which will take 30-45 minutes to infuse. These treatments will be repeated once every three weeks for 6 cycles of chemotherapy (18 weeks).
  • Before each chemotherapy treatment the following tests and procedures will be performed: physical exam and medical history; evaluation of ability to undertake daily activities; and blood tests.
  • After every 2 cycles of chemotherapy (every 6 weeks) patients will have a CT or MRI scan to measure how well their cancer is responding to treatment.
  • The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not grow and the patient isn't experiencing any severe side effects.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  • Bidimensionally measurable disease which can be measured by physical examination or by means of medical imaging techniques (measurable disease).
  • OR Two confirmed serum CA-125 levels greater than or equal to 70 u/ml (or 2x 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 be at least 18 years of age.
  • Patients must have a GOG performance status of 0, l, or 2.
  • WBC > 3,00/mm3
  • Neutrophils > 1,500/mm3
  • Platelets > 100,000/mm3
  • Total Bilirubin < 1.5 ULN
  • Calculated creatinine clearance > 45 ml/min
  • ALT/AST < 3 x ULN (no liver mets) ALT/AST < 5 x ULN (with liver mets)
  • SGOT, SGPT, alkaline phosphatase ≤ three times the upper normal institutional limits.
  • All labs must be drawn within 4 weeks prior to entry to the study
  • 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 NSAID intake for 2 days before, day of, and 2 days after each chemotherapy treatment. Low dose 80mg aspirin and 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, bloodwork and any clinically indicated imaging studies within 4 weeks prior to study enrollment.
  • Baseline folate and homocysteine blood levels.
  • 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 (≥ 4500cGy) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001910

Contacts
Contact: Loraine Centrilla, RN 718.405.8082 lcentril@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Loraine Centrilla, RN    718-405-8082    lcentril@montefiore.org   
Principal Investigator: Dennis Yi-Shin Kuo, MD         
Sub-Investigator: Mark H. Einstein, MD, MS         
Sub-Investigator: Gary L. Golberg, MD         
Sub-Investigator: Gloria Shining Huang, MD         
Sub-Investigator: Shoreh Shahabi, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Dennis Yi-Shin Kuo, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Dennis Yi-Shin Kuo, MD, Montefiore Medical Center and Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01001910     History of Changes
Other Study ID Numbers: MMC-08-04-097
Study First Received: October 26, 2009
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Pemetrexed
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014