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Trial record 68 of 526 for:    "Primary Peritoneal Carcinoma"

Outcomes in CRS/HIPEC as Initial Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Cancer (CRS/HIPEC)

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ClinicalTrials.gov Identifier: NCT02124421
Recruitment Status : Recruiting
First Posted : April 28, 2014
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mercy Medical Center

Brief Summary:
Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Stage III Ovarian Cancer Stage IV Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Ovarian Carcinoma Fallopian Tube Carcinoma Procedure: Cytoreductive Surgery (CRS) Drug: Adjuvant Chemotherapy Other: Questionnaire Procedure: Hyperthermic intraperitoneal chemotherapy Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin Phase 2

Detailed Description:

Primary endpoints:

  • To assess the feasibility of recruitment
  • Compare complication rates between the two study arms: CRS with HIPEC and CRS alone.

Secondary endpoints:

  • To determine risk factors for morbidity and mortality
  • Assess completion rate of 6 cycles of systemic chemotherapy
  • To determine progression free survival at 24 months
  • To determine overall survival at 1, 3, and 5 years
  • Evaluate health related quality of life

Patients who meet study criteria will be randomized into one of two treatment arms: 1) cytoreductive surgery (CRS) with carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by IV combination chemotherapy with carboplatin and paclitaxel or 2) cytoreductive surgery (CRS) alone followed by adjuvant intraperitoneal (IP) and IV chemotherapy with combination cisplatin and paclitaxel for newly diagnosed advanced stage (stage III/IV) ovarian, fallopian tube or primary peritoneal cancer. Both study arms will receive 6 cycles of adjuvant chemotherapy.

Twenty-four patients will undergo CRS with HIPEC performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175mg/m2) for 6 cycles postoperatively.

Twenty-four patients will undergo CRS only performed by surgical and gynecologic oncologic surgeons at Mercy Medical Center, followed by IV/IP chemotherapy with Day 1: IV paclitaxel (135 mg/m2), Day 2: IP cisplatin (75 mg/m2), and Day 8: IP paclitaxel (60 mg/m2) for 6 cycles postoperatively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Study: Cytoreductive Surgery (CRS) With/Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Adjuvant Chemotherapy as Initial Treatment of Ovarian, Fallopian Tube, & Primary Peritoneal Cancer
Study Start Date : April 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Active Comparator: CRS with adjuvant IV/IP chemotherapy
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
Procedure: Cytoreductive Surgery (CRS)
Cytoreductive surgery
Other Name: CRS

Drug: Adjuvant Chemotherapy
Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles
Other Names:
  • Post-operative chemotherapy
  • Systemic chemotherapy

Other: Questionnaire
Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants
Other Name: FACT-O Questionnaire

Drug: Paclitaxel
Day 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
Other Name: Taxol

Drug: Cisplatin
Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
Other Name: CDDP

Experimental: CRS/HIPEC with adjuvant IV chemotherapy
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
Procedure: Cytoreductive Surgery (CRS)
Cytoreductive surgery
Other Name: CRS

Drug: Adjuvant Chemotherapy
Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles
Other Names:
  • Post-operative chemotherapy
  • Systemic chemotherapy

Other: Questionnaire
Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants
Other Name: FACT-O Questionnaire

Procedure: Hyperthermic intraperitoneal chemotherapy
Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6
Other Name: HIPEC

Drug: Carboplatin
AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.
Other Name: Paraplatin

Drug: Paclitaxel
175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles
Other Name: Taxol




Primary Outcome Measures :
  1. Post-operative complication rates [ Time Frame: 30 days post-operative ]
    Compare post-operative complication rates between study arms


Secondary Outcome Measures :
  1. Assessment of quality of life [ Time Frame: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5 ]
    FACT-O questionnaire to assess quality of life in both study arms

  2. Evaluate the rate of progression free survival [ Time Frame: at 24 months ]
    Time from intervention to disease recurrence

  3. Evaluate overall survival [ Time Frame: at 1, 3, and 5 years ]
    Time from intervention to death


Other Outcome Measures:
  1. Risk factors for morbidity and mortality [ Time Frame: During & at study completion ]
    Determine percent of patients wtih Grade I-V adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical presentation of ovarian, fallopian tube or primary peritoneal cancer
  • Stage III/IV disease
  • No prior treatment or significant surgery for the management of ovarian, fallopian tube, or primary peritoneal carcinoma; History of laparoscopic procedures to obtain diagnostic biopsies will be permitted in the study
  • Histological confirmation
  • Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
  • ≤1 cm residual disease at the completion of the cytoreductive surgery (GOG criteria for optimally cytoreduction)
  • Bone marrow function:

    1. Absolute neutrophil count (ANC) ≥1,000/mm3
    2. Platelets ≥100,000/mm3
    3. Hemoglobin ≥ 8.5 g/dL
  • Renal function:

    1) Creatinine ≤1.5 times the upper limit of normal or a calculated creatinine clearance ≥60ml/min

  • Hepatic function:

    1. Bilirubin ≤1.5 times upper limit of normal
    2. Alanine aminotransferase (ALT) ≤3 times upper limit of normal
    3. Aspartate aminotransferase (AST) ≤3 times upper limit of normal
  • Blood coagulation parameters:

    1. Prothrombin time (PT) with International Normalized Ratio of ≤1.5 and a partial prothrombin time (PTT) ≤1.5 times upper limit of normal
    2. For patients on full dose warfarin, in range International Normalized Ratio (usually between 2 and 3) and
    3. Partial prothrombin time (PTT) <1.2 times upper limit of normal
    4. Candidate for administration of postoperative standard platinum-based combination systemic chemotherapy (adequate bone marrow, renal, hepatic function, and blood coagulation parameters)

Exclusion Criteria:

  • Any prior treatment modality for the diagnosis of ovarian, fallopian tube, or primary peritoneal cancerPrior surgical attempt of cytoreductive surgery
  • Stage I/II disease
  • Presence of other invasive malignancies or evidence of other cancer within the past 3 years
  • Known active acute hepatitis and confirmed diagnosis of HIV
  • Active systemic infection that requires use of parenteral antibiotics
  • History of acute coronary syndromes (ACS), within the last 6 months, according to AHA definitions
  • New York Heart Association (NYHA) Class II or higher congestive heart failure according to American Heart Association (AHA) definitions
  • Canadian Cardiovascular Society (CCS) Class II or higher angina grade according to AHA definitions
  • Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at time of consent by cardiologist
  • History of cerebral artery disease and prior stroke according to AHA definitions in the last 6 months
  • Renal insufficiency with serum creatinine level ≥1.5 times the upper limit of normal or calculated creatinine clearance <60 ml/min
  • Patients with concurrent severe medical problems unrelated to malignancy that will preclude compliance with the study or places at an unacceptable risk for participation in the study determinate by study investigators
  • Pregnant women are excluded from this study because carboplatin is category D agent with the potential of teratogenic effects. Due to potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin, breastfeeding should be discontinued
  • Life expectancy of < 12 weeks

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): NCT02124421


Contacts
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Contact: Michelle Sittig, RN 410-332-9294 msittig@mdmercy.com

Locations
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United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Sub-Investigator: Teresa Diaz-Montes, M.D., M.P.H         
Principal Investigator: Armando Sardi, M.D.         
Sponsors and Collaborators
Mercy Medical Center
Investigators
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Principal Investigator: Teresa Diaz-Montes, M.D. Mercy Medical Center
Principal Investigator: Armando Sardi, M.D. Mercy Medical Center

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Responsible Party: Mercy Medical Center
ClinicalTrials.gov Identifier: NCT02124421     History of Changes
Other Study ID Numbers: MMC-2014-17
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Keywords provided by Mercy Medical Center:
Ovarian cancer
Cytoreductive surgery
Hyperthermic Intraperitoneal chemotherapy
Systemic chemotherapy
Primary peritoneal carcinoma
Fallopian Tube cancer
Intraperitoneal chemotherapy
IV/IP chemotherapy
IV chemotherapy

Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action