Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

NCT00072228 | Withdrawn Phase 1

• 4 other identifiers: DAIICHI-1027A-PRT008CDR0000339345CPMC-IRB-20031085NCT00072228
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, 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 soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

gemcitabine DRUG

soblidotin DRUG

chemotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed locally advanced or metastatic solid tumors * Minimally pretreated * Not refractory to prior gemcitabine therapy * No disease progression during initial treatment with gemcitabine * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * Ejection fraction at least 40% by MUGA Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychiatric disorder that would preclude study consent or compliance * No concurrent severe or uncontrolled underlying medical disease unrelated to the tumor that would compromise patient safety or affect study outcome * No hypersensitivity to gemcitabine * No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off all therapy for that disease for at least 2 years * No serious infection * No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic therapy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * Recovered from prior radiotherapy * No concurrent anticancer radiotherapy * Concurrent localized palliative radiotherapy to a non-indicator lesion for pain control allowed only if other methods of pain control are ineffective Surgery * At least 4 weeks since prior major surgery and recovered Other * More than 28 days since prior investigational drugs, including analgesics or antiemetics * At least 4 weeks since prior myelosuppressive therapy * No other concurrent anticancer therapy * No other concurrent anticancer cytotoxic therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Pharmaceuticals: lead

Study Sites (2)

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Gemcitabine; soblidotin; Drug Therapy

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Robert L. DeJager, MD, FACP

  Daiichi Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Last Updated: July 10, 2013

Record last verified: 2006-12

Locations

US (2)