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Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01519869
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rachel Miller, University of Kentucky

Study Description
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Brief Summary:
This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable survival, decreased morbidity, and increased quality of life in patients with International Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or fallopian tube cancer when compared to historical controls and to evaluate the hypothesis that cancer induced inflammation is a predictor of poor prognosis and response to therapy in this group of ovarian cancer patients.

Condition or disease Intervention/treatment Phase
Primary Peritoneal Carcinoma Ovarian Carcinoma Fallopian Tube Carcinoma Drug: neoadjuvant chemotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Platinum-based Chemotherapy in Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma Trial Protocol
Actual Study Start Date : March 2012
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: neoadjuvant chemotherapy
platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
 Drug: neoadjuvant chemotherapy
platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients That Achieve Maximal Surgical Debulking [ Time Frame: 5 years ]
    Percentage of patients that achieve maximal surgical debulking as defined by no gross residual disease following a Simon's 2-stage design.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with biopsy proven stage IIIC/IV epithelial ovarian cancer, primary peritoneal, fallopian tube carcinoma. If a core biopsy is not possible, fine-needle aspirate showing adenocarcinoma is acceptable in the setting of a pelvic mass and presence of metastasis outside the pelvis measuring at least 2 cm, regional lymph-node metastasis or proof of stage IV disease, and ratio of CA 125 to CEA greater than 25. If CA 125 to CEA ratio is 25 or lower, barium enema, gastroscopy, and mammography must be negative.

  • Patients must have adequate:

    • Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/μl, equivalent to Common Toxicity Criteria for Adverse Events v3.0(CTCAE) Grade 1. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.
    • Platelets greater than or equal to 100,000/μl, CTCAE Grade 0-1. Renal function: Creatinine ≤1.5 x institutional upper limit of normal ULN), CTCAE Grade 1.
    • Hepatic function: Bilirubin ≤ 1.5 x ULN, CTCAE Grade 1.SGOT and alkaline phosphatase ≤ 2.5 x ULN, CTCAE Grade 1.
    • Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.
    • Blood coagulation parameters: PT such that international normalized ratio (INR) is ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis) and a PTT <1.2 x ULN.
  • Patients must have a World Health Organization Performance Status ≤2.
  • Patients must be a candidate for surgery.
  • An approved informed consent must be signed by the patient.

Exclusion Criteria:

  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
  • Patients with a known synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than IA, no more than superficial myometrial invasion, without vascular or lymphatic invasion, no poorly differentiated subtypes (including papillary serous, clear cell or other FIGO Grade 3 lesions).
  • With the exception of non-melanoma skin cancer and other specific malignancies noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this therapy are excluded.
  • Patients with acute hepatitis or active infection that requires parenteral antibiotics are excluded.
  • Patients with World Health Organization Performance Status of 3 or 4.
  • Patients who are pregnant or nursing.
  • Patients under the age of 18.
  • Patients with a pelvic mass of any size that is causing pain, or other subjective symptoms that are intolerable to the patient.
  • Patients who are not candidates for interval surgical debulking secondary to significant medical comorbidities.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519869


Locations
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United States, Kentucky
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Rachel Miller
Investigators
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Principal Investigator: Rachel Miller, MD Lucille P. Markey Cancer Center at University of Kentucky
  Study Documents (Full-Text)

Documents provided by Rachel Miller, University of Kentucky:
Study Protocol and Statistical Analysis Plan  [PDF] November 11, 2014
Informed Consent Form  [PDF] September 23, 2015

More Information
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Responsible Party: Rachel Miller, Assistant Professor, Obstetrics and Gynecology, University of Kentucky
ClinicalTrials.gov Identifier: NCT01519869    
Other Study ID Numbers: 11-GYN-098-MCC
First Posted: January 27, 2012    Key Record Dates
Results First Posted: December 14, 2020
Last Update Posted: December 14, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Miller, University of Kentucky:
peritoneal
carcinoma
ovarian
 fallopian tube
neoadjuvant chemotherapy
surgical debulking
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms