Comparing Combination Chemotherapy Regimens in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by NCIC Clinical Trials Group
Sponsor:
Collaborators:
Grupo Español de Investigación en Cáncer de Ovario
Cancer Research UK
Southwest Oncology Group
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00993655
First received: October 9, 2009
Last updated: July 14, 2014
Last verified: March 2014
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with ovarian epithelial cancer, primary peritoneal cancer, and fallopian tube cancer.

PURPOSE: This randomized phase II/III trial is comparing the side effects of three combination chemotherapy regimens and to see how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Metastatic Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel
Procedure: quality-of-life assessment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II/III Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • 9-month progression rate post-randomization [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Completion rate of treatment (based on toxic effects and feasibility) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Toxic effects as evaluated after each cycle and periodically after completion of therapy [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Quality of life as measured by EORTC QLQ-C30, ovarian cancer module (EORTC QLQ-OV28), and FACT/GOG-Ntx questionnaires on day 1 cycle 2, day 1 cycle 3 and at end of last cycle [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free and Overall survival (Phase III) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Toxic effects (Phase III) [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
  • Quality of life (Phase III) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Correlative biological studies (Phase III) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Economic evaluation (Phase III) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Outcomes associated with variation in nursing-related practices as measured by nursing management questions worksheet for IP chemotherapy administration on day 1 and 8 of each cycle of IP treatment (Phase III) [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: September 2009
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
ARM 1: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intravenous day 1; Paclitaxel 60 mg/m2 intravenous day 8. Cycles given Q 21 days x 3 cycles
Drug: carboplatin
Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.
Drug: paclitaxel
Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
Active Comparator: Arm 2
ARM 2: Paclitaxel 135 mg/m2 intravenous day 1 plus Cisplatin 75 mg/m2 intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles (Phase II cisplatin arm closed to accrual on 2014-FEB-03)
Drug: cisplatin
Cisplatin 75 mg/m2 intraperitoneal day 1
Drug: paclitaxel
Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
Procedure: quality-of-life assessment
day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy
Active Comparator: Arm 3
ARM 3: Paclitaxel 135 mg/m2 intravenous day 1 plus Carboplatin AUC 5 if measured GFR or AUC6 if estimated GFR intraperitoneal day 1; Paclitaxel 60 mg/m2 intraperitoneal day 8. Cycles given Q 21 days x 3 cycles
Drug: paclitaxel
Paclitaxel 135 mg/m2 intravenous day 1 plus Paclitaxel 60 mg/m2 intraperitoneal or intravenously day 8. Cycles given Q 21 days x 3 cycles
Procedure: quality-of-life assessment
day 1 cycle 2, day 1 cycle 3 and at 3, 6, 12 mo then annually until disease progression, death or initiation of second-line therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, primary serous type peritoneal, or fallopian tube carcinoma

    • Patients with ovarian cancer of the clear cell histology are eligible. Histologic confirmation is preferably by biopsy or limited excision prior to neo‐adjuvant treatment. If the diagnosis prior to neo-adjuvant chemotherapy is based on cytology, histologic confirmation is required prior to randomization. Histologic confirmation can be obtained at the time of debulking surgery by intra-operative frozen section, thus permitting intra-operative randomization, or by final pathologic review of the resected specimen if randomization is to be performed following debulking surgery.
    • Initial FIGO stage IIB-III disease

      • Stage IV disease allowed provided the only criterion for stage IV disease is the presence of a pleural effusion confirmed to be associated with positive cytology for ovarian cancer
  • Completed ≥ 3 but no more than 4 courses of platinum-based neoadjuvant chemotherapy prior to the first debulking surgery
  • Meets the following criteria for surgical treatment prior to randomization:

    • Initial Diagnosis: No debulking surgery was attempted or completed.
    • The patient's first cytoreductive (debulking) surgery must be after neoadjuvant chemotherapy (Delayed Primary Debulking). The delayed primary debulking surgery must be completed no more than 4 weeks after commencing administering of the last cycle of neoadjuvant chemotherapy and must be completed no more than 6 weeks prior to randomization.
    • Surgery will include total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy and any additional procedures required to achieve maximal cytoreduction with residual disease of 1 cm or less as assessed by the surgeon at the end of surgery.

      • Delayed primary debulking surgery must be completed no more than 4 weeks after the last course of neoadjuvant chemotherapy and must be completed no more than 6 weeks prior to randomization
    • Surgery will include total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and any additional procedures required to achieve maximal cytoreduction with residual disease of ≤ 1 cm as assessed by the surgeon at the end of surgery
  • No borderline ovarian tumors (i.e., tumors of low malignant potential) alone
  • No mucinous tumor

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Granulocyte count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Serum creatinine ≤ upper limit of normal (ULN) OR > ULN to ≤ 1.25 ULN provided measured creatinine clearance is > 60 mL/min
  • Serum bilirubin normal
  • AST/ALT ≤ 2.5 times ULN
  • Fertile patients must use effective contraception
  • Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires
  • Accessible for treatment and follow-up
  • No history of other malignancy, except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
  • No uncontrolled atrial or ventricular arrhythmias including second or third degree heart block unless managed with implanted pacemaker

    • Patients with a history of first degree heart block are eligible
  • No documented myocardial infarction within the past 6 months preceding randomization (pretreatment ECG evidence only of infarct will not exclude patients)
  • No diagnosis of bowel obstruction
  • No serious illness or medical condition which would not permit the patient to be managed according to protocol including, but not limited to, any of the following:

    • Prior allergic reactions to drugs containing cremophor or to compounds chemically related to cisplatin, paclitaxel, or carboplatin
    • Symptomatic congestive heart failure within the past 6 months or other conditions which would lead to a contraindication of a high-volume saline diuresis
    • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent
    • Active uncontrolled infection
    • Persistent peripheral neuropathy or hearing loss ≥ grade 2 resulting from prior therapy
    • Extensive intraperitoneal adhesion intra- or post-operatively which would impede intraperitoneal treatment delivery

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior therapy for ovarian cancer, except for neoadjuvant platinum-based chemotherapy and surgery
  • No concurrent intraperitoneal adhesion barriers
  • No other concurrent anticancer treatment, including cytotoxic agents, biological response modifiers, immunotherapy, anticancer hormone therapy, or investigational drug therapy
  • No other concurrent experimental drugs or anticancer therapy
  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: NCT00993655

Contacts
Contact: Elizabeth Eisenhauer 613-533-6430 eeisenhauer@ctg.queensu.ca

  Show 49 Study Locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Grupo Español de Investigación en Cáncer de Ovario
Cancer Research UK
Southwest Oncology Group
Investigators
Study Chair: Helen J. Mackay, MD Princess Margaret Hospital, Canada
Study Chair: Diane M. Provencher, MD, FRCS, FACOG Hopital Notre-Dame du CHUM
  More Information

Additional Information:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00993655     History of Changes
Other Study ID Numbers: OV21, CAN-NCIC-OV21, UCL08/0379, GEICO-0902, SWOG OV.21, CDR0000655241
Study First Received: October 9, 2009
Last Updated: July 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by NCIC Clinical Trials Group:
peritoneal cavity cancer
fallopian tube cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
malignant pleural effusion
ovarian clear cell cystadenocarcinoma
ovarian clear cell tumor with proliferating activity

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
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
Neoplasms by Histologic Type
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014