URCC U1105

KCCOP Protocol Summary

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full protocol.
Members may follow the "Full Protocol" link or contact KCCOP for complete protocol information.

Full Protocol

(members only)

Consent Form

HIPAA

URCC U1105 - "Prevention of Delayed Nausea: A Phase III Double-Blind Placebo-Controlled Clinical Trial"

Treatment Plan (Supplied Drugs: All study meds & matching placebos)

	Day 1	Days 2 & 3
		AM	Mid-Day	Evening
Arm 1	Palonosetron, 0.25mg, IV Dexamethasone, 20mg, IV Placebo, PO	Compazine, 10mg, PO Placebo, PO	Compazine, 10mg, PO	Compazine, 10mg, PO
Arm 2	Granisetron, 1mg, IV Dexamethasone, 20mg, IV Placebo, PO	Compazine, 10mg, PO Placebo, PO	Compazine, 10mg, PO	Compazine, 10mg, PO
Arm 3	Palonosetron, 0.25mg, IV Dexamethasone, 12mg, IV Aprepitant, 125mg, PO	Aprepitant, 80mg, PO Dexamethasone, 8mg, PO	Placebo, PO	Placebo, PO
Arm 4	Palonosetron, 0.25mg, IV Dexamethasone, 20mg, IV Placebo, PO	Compazine, 10mg, PO Dexamethasone, 8mg, PO	Compazine, 10mg, PO	Compazine, 10mg, PO

Eligibility

Have cancer dx and chemo naive.
Scheduled to receive chemo tx containing Cisplatin (any dose or schedule), Carboplatin (any dose or schedule), Oxaliplatin (any dose or schedule), Doxorubicin (any dose or schedule) or Epirubicin (any dose or schedule) w/o concurrent RT or Interferon tx.
- Chemo may be for adjuv, neoadjuv, curative, or palliative intent.
- Dose-dense regimens are allowed.
- Day 1 of chemo will be defined as day of Cisplatin, Carboplatin, Oxaliplatin, Doxorubicin, or Epirubicin administration.
- No regimens w/multiple-day doses of Doxorubicin, Epirubicin, Cisplatin, Carboplatin, Oxaliplatin, Dacarbazine, Hexamethylmelamine, nitrosoureas, or Streptozocin. Chemo agents, other than those listed above, may be given PO, IV, or CI on 1 or multiple days.
- No regimens containing liposomal Doxorubicin or liposomal Cisplatin. (NOTE: Section 4.2.5 of URCC's full protocol is unclear. KCCOP's wording has been clarified.)
No clinical evidence of current or impending bowel obstruction or symptomatic brain mets.
No current use of pimozide, terfenadine, astemizole, or cisapride.
Able to understand English.
Age >18.
PRESTUDY REQUIREMENTS:
- Godin Exercise Questionnaire
- Brief Fatigue Inventory
- Osoba Nausea & Emesis Module
- FACT-G
Signed informed consent.