Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer
Condition: Fallopian Tube Cancer; Metastatic Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: carboplatin; cisplatin; paclitaxel
Intervention description: Carboplatin AUC 5 if measured GFR or AUC6 if calculated GFR intravenous or intraperitoneal.; Cisplatin 75 mg/m2 intraperitoneal day 1; 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
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 275.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      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 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.
    

Eligibility 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