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A Double-Blind, Multicenter, Parallel Study Comparing the Efficacy and Safety of Kytril Tablets With Placebo, in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-Based or Carboplatin-Based Chemotherapy in Patients With Malignant Disease


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Double-Blind, Multicenter, Parallel Study Comparing the Efficacy and Safety of Kytril Tablets With Placebo, in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-Based or Carboplatin-Based Chemotherapy in Patients With Malignant Disease


OBJECTIVES: I. Compare the efficacy and safety of oral granisetron versus placebo in
preventing nausea and vomiting during the 48 hours that begins 24 hours after administration
of cyclophosphamide-based or carboplatin-based chemotherapy regimens in patients with
malignant disease.

OUTLINE: This is a randomized, double blind, placebo controlled, parallel, multicenter
study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral
granisetron on day 0 at 60 minutes prior to the scheduled administration of IV
cyclophosphamide or carboplatin (or doxorubicin) chemotherapy. On days 1 and 2, patients
receive oral granisetron at approximately the same time as on day 0. Arm II: Patients
receive oral granisetron on day 0 as in arm I. On days 1 and 2, patients receive oral
placebo at approximately the same time as the granisetron tablets were taken on day 0.
Patients are followed between 5 and 11 days after the last dose of study medication.

PROJECTED ACCRUAL: A total of 434 patients (217 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of malignant disease eligible for chemotherapy
Scheduled to receive a regimen of chemotherapy containing IV cyclophosphamide or
carboplatin, with or without other chemotherapy agents Cyclophosphamide must be given at a
dose of 500-1,200 mg/m2 Carboplatin must be given at a dose of at least 300 mg/m2 unless
Calvert dosing equation (using target AUC of 6 mg/mL/min) requires less than 300 mg/m2
Doxorubicin, if given, must be infused within a period not exceeding 1 hour Minimum doses
are to be based on actual body weight Other emetogenic or nonemetogenic agents are
permitted to be included in the day 0 chemotherapy regimen without restriction on dose
Emetogenic agents must be given as part of cyclophosphamide-based or carboplatin-based
regimen on day 0 and not at another time within the 72 hour period Cyclophosphamide,
carboplatin, or doxorubicin must be the first emetogenic agent given No cyclophosphamide,
doxorubicin, vincristine, and prednisone (CHOP) regimen No primary or secondary (from
metastatic disease) brain neoplasm with: Signs or symptoms of increased intracranial
pressure OR Brain metastases requiring treatment within 30 days of study entry No signs or
symptoms of cerebral edema Symptomatically "silent" metastasis allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No unstable medical disorder No known hypersensitivity to any 5HT3
receptor antagonist At least 1 hour since prior nausea and/or at least 24 hours since
prior emesis (i.e., vomiting and/or retching)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior emetogenic chemotherapy Prior nonemetogenic chemotherapy (dose
and/or agent) allowed provided antiemetic agents were not required and nausea and emesis
did not result Endocrine therapy: No chronic (more than 1 month) or concurrent
corticosteroids except for replacement or maintenance doses up to 10 mg prednisone or
equivalent or prophylactic pretherapy with dexamethasone on day 0 Radiotherapy: At least
24 hours since prior radiotherapy to any abdominal field (T10-L5) No concurrent
radiotherapy to any abdominal field (T10-L5) Prior or concurrent radiotherapy to other
fields allowed (e.g., pelvic irradiation, thoracic irradiation) Surgery: Not specified
Other: At least 30 days or 5 half-lives (whichever is longer) since prior investigational
drugs At least 8 hours since prior other short acting agents administered for procedures
(e.g., port insertion) At least 8 hours since prior and no concurrent benzodiazepines
Concurrent narcotic analgesics allowed provided receiving for at least 1 week prior with
no nausea or emesis No chronic (more than 1 month) or concurrent agents known to have a
significant effect on emesis (e.g., antipsychotics, cannabinoids, metoclopramide, and 5HT3
receptor antagonists) No other concurrent prophylactic antiemetics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Barbara J. Gitlitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067540

NCT ID:

NCT00005024

Start Date:

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

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