DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor

• Locally advanced or metastatic disease

• Minimally pretreated

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

• Bilirubin no greater than 1.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Gastrointestinal

• No prior chronic diarrhea

• No swallowing and/or malabsorption problems

• No diarrhea (excess of 2-3 stools/day above normal frequency in the past month)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No prior severe or life-threatening hypersensitivity reaction to a taxane or capecitabine

• No concurrent serious infection

• No neuropathy grade 2 or greater

• No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other severe or uncontrolled underlying medical disease that would preclude study participation

• No psychiatric disorder that would preclude giving informed consent or study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anticancer biologic therapy

Chemotherapy

• Recovered from prior chemotherapy

• No other concurrent anticancer chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Recovered from prior radiotherapy

• No concurrent anticancer radiotherapy

• Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective

Surgery

• At least 4 weeks since prior major surgery and recovered

• No prior major surgery in the stomach or small intestine

Other

• At least 4 weeks since prior myelosuppressive therapy

• More than 28 days since prior investigational drugs (including analgesics and/or antiemetics)

• No other concurrent anticancer therapy

• No other concurrent anticancer cytotoxic therapy