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

Status:

WITHDRAWN

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

Lead Sponsor:

Daiichi Pharmaceuticals

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 ...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors. * Determine the dose-limiting toxic effects of ...

Eligibility Criteria

Inclusion

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

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00072228

Last Update

July 10 2013

Active Locations (2)

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Page 1 of 1 (2 locations)

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States, 87131-5636