RATIONALE: Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of granisetron with that of a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant disease.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: carboplatin  Drug: cyclophosphamide  Drug: doxorubicin  Drug: granisetron	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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)

Study chairs or principal investigators

Barbara J. Gitlitz,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067540; UCLA-9904005; NCI-G00-1674; SB-BRL43694A/513
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005024
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08